CLISTER
- Clinical Surgical Trials Epidemiological Research
STUDIES
Abdominal rectus diastasis
In this prospective, randomised, clinical trial, two different operative techniques for repair of abdominal rectus diastasis are evaluated.
Between the surgical specialty and the field of reconstructive plastic surgery, opinions differ whether a rectus diastasis larger than three centimetres should be reconstructed and enforced with mesh, or with a permanent double-row plication. Evidence-based data comparing these techniques does not exist.
This study will randomise the patients with abdominal rectus diastasis to one of the described alternatives. All patients will be evaluated preoperatively. Computed tomography of the abdominal wall, and a validated quality of life analysis, will be performed both preoperatively and twelve months after the surgery. The abdominal wall strength will be studied through BioDex measurement.
Bulging after nephrectomy with flank incision
This study aims to prevent the intractable incisional hernias that sometimes follow partial or complete nephrectomy (removal of the kidney through laparoscopy). This kind of hernia decreases the stability in the patient’s abdomen, and may cause severe pain which can make a normal social and work-oriented life difficult.
The presence of these hernias is unknown. Similar to other hernias though, some risk factors can be suspected to increase the risk of hernia; smoking, diabetes, overweight, lowered immune system, bad nutritional status and emergency surgery. If hernias develop following these nephrectomies, they are difficult to reconstruct. The most common method is trying to cover the hernia and abdominal cavity with mesh during surgery. The risk of relapse is high, and other methods are unavailable.
This study investigates whether biological material inserted in the area during the primary operation, among risk patients, can prevent incisional hernia without adding risks for the patient.
CT UL OP
In up to 50 % of the times a stoma is created through the abdominal wall, the orifice becomes too large or either the abdominal wall or the stoma orifice weakens. This could result in a bulge in the abdominal wall, or that bowel or other abdominal content presses against the stoma.
To correctly diagnose whether it is a hernia in the stoma orifice or beside the stoma, or a bulge, is clinically difficult. This has mainly been done through computer tomography of the abdominal wall, which adds more radiation to a patient who, in many cases, already has gone through repeated x-ray examinations.
This study examines whether 3D ultrasonography inside the stoma would provide a more secure image of the anatomy to better determine the cause and enable a correct treatment of the patient.
Emergency resection for colon cancer
Of all patients undergoing resection for colon cancer in Sweden, 21.5 % (of 4000 cases/year) are classified as emergency resections. Emergency resections are associated with a worse outcome both in terms of short- and long-term survival compared to those undergoing elective surgery. These resections are also associated with an increased risk of local cancer relapse. The reason for this is unknown.
An awareness of the reasons would enable the option of making better considerations regarding whether patients would benefit or not from different treatments. It could also be a foundation for preventing the negative factors already associated with these emergency resections. This study is aimed at finding the factors causing the lower survival rate and the increased relapse frequency that is present within the group undergoing emergency resection for colon cancer. Among other things, the distance to the hospital performing the surgery in regards to whether the patient needs emergency resection or not will be investigated.
Fecal incontinence
Damages to the anal sphincter might cause a risk of fecal incontinence, and thereby significant effects on future work, family life and recreational time. Reasons for this injury can be a badly repaired muscle following childbirth, an undiscovered birth injury, or anal surgery.
3D ultrasound is the most important diagnostic tool for identifying these damages. The surgical method for sphincter injuries has changed over the past years, so that the muscle and the perineum are both constructed. This method has yet to be evaluated.
This study intends to
a. Survey the extent of fecal incontinence following child birth through questionnaires for women with severe birth injuries
b. Examine the functional results that a modern method of surgery leads to
c. Investigate whether early training of the sphincter enables a better function
d. Investigate whether active conversional therapy in connection to surgery for fecal incontinence leads to a more active sex life
e. Investigate association between delivery method and fecal incontinence, through a retrospective epidemiological study among women within the Northern region, whom have gone through child birth during 2013
f. Survey the extent of fecal incontinence among a cohort of men.
A parastomal hernia develops in 3–80 % of patients with a stoma. Surgical methods currently used in parastomal hernia repair involves reinforcing the abdominal wall with a synthetic mesh. However, these methods often result in recurrence of the hernia, and the mesh can also cause serious complications such as fistulas between the intestine and the mesh. The most commonly used method today is to place the mesh inside the abdominal cavity, as this method seems to produce fewer recurrences, but international guidelines lack clear recommendations due to the lack of high-quality studies.
Our research group has developed a method where a transplant of the patient's own (autologous) skin is used as a reinforcement of the abdominal wall in parastomal hernia repair. This new surgical method is being evaluated in the SHIFT-study (Stoma Hernia Intraperitoneal Full-Thickness skin). SHIFT is a randomised multicentre study in which a synthetic reinforcement material (Dynamesh IPST™) is compared to an autologous full-thickness skin grafts during surgery for symptomatic parastomal hernias. The primary outcome is surgical complications, but the study participants' quality of life and pain, incidence of recurrence and health economics will also be evaluated. Through the use of an autologous tissue, for which there is no foreign body reaction, our new method could potentially be used in a very difficult-to-treat condition. Furthermore, some of the synthetic meshes used today are expensive, and the method could mean a significant cost saving.
In parallel with the main study, tissue samples will also be collected in connection with the primary operation as well as blood samples during the clinical follow-ups. In these samples, the characteristics of the study participants' connective tissue and the connective tissue turnover will be studied. It will teach us more about the underlying causes of hernia disease and enable a more tailored treatment.
SHIFT
Inguinal hernia repair
Striving for safety and quality
This study intends to enable an improved model of inguinal hernia repair. We will investigate to what extent different complications following inguinal hernia surgery increase the risk of chronic inguinal pain.
The Inguinal Pain Questionnaire (IPQ) is a questionnaire regarding inguinal pain following surgery. Currently, this questionnaire contains 18 questions. Within this study a shortened version will be evaluated and validated, since an alternative version with fewer questions would facilitate using this form.
The presence of severe complications during laparoscopic inguinal hernia will be investigated as well. The study also intends to survey the adherence to a local care programme and its effect on the quality within emergency hernia surgery.
GUMP
Unhealthy overweight and comorbidity can in many cases be successfully treated through bariatric surgery. The effects on overweight and comorbidity are well documented, but complications are present in around 7 % of the cases, and other bodily changes may also be of significance.
The overall aim of this study is to create a knowledge database for targeted prophylactic measurements against surgical complications following bariatric surgery, and to survey the tissue’s biological and physiological effects on the abdominal wall function and leg muscle strength.
Fields that will be looked into are how some drugs can prevent complications, how socio-economic status affects the result as well as early and late complications following bariatric surgery, how the altered metabolism and the weight loss affects muscle strength in legs and abdomen, and how different factors might affect the complication rate.
LISTO
In Northern Europe, especially in Sweden, loop ileostomies have had a bit of a renaissance in connection with anastomosis of the lower part of the rectum after surgery for rectum cancer. During later years, it has been discovered that relieving such an anastomosis with a loop ileostomy, hence leading the fecal current away from a sensitive area, reduces the risk for troubling complications and leakage. The loop ileostomy is a method preferred by more and more surgeons since it reduces the risk of infections in the perineum after surgery for rectum cancer. This method, though, is connected with some inconvenient elements; apart from the patient needing one more surgery to reverse the ileostomy three to six months after the major procedure, complications connected to the reversal might occur.
Generally, there are two different methods for the reversal of a loop ileostomy; hand-sewn or stapled. The latter provides a significantly larger canal, but is also connected with higher costs, and possibly also bigger preparations in relation to the hand-sewn. This study examines which method gives the least complications.
MSI and colorectal cancer
Colorectal cancer is the second most common type of cancer among both men and women in Sweden. The curative treatment is surgery, sometimes combined with radio- or chemotherapy. Colorectal cancer can be divided into different stages, I-IV, through identifying the tumour’s penetration into the intestinal wall, spreading to lymph nodes and spreading to other organs. Stage II means that the tumour has grown through the intestinal wall, but without a presence of known metastases in lymph nodes or other organs. Today, most stage II tumours are preoperatively treated with radio- or chemotherapy.
Today it’s well studied that some colorectal tumours are caused by errors in the process that replicates DNA during cell division. The cell has different systems for identifying and repairing such errors. One of these systems is called mismatch repair system (MMR). Dysfunction in the MMR-system causes genetic instability, mutations during DNA replication, known as microsatellite instability (MSI).
MSI is identified in 15 % of all colorectal cancer. At present, two methods can assess MMR function and identify MSI. The first, most commonly used, is Polymerase Chain Reaction (PCR) that can be performed with fresh, frozen or paraffin treated tumour tissue. The analysis is built on an examination of five identified markers. MSI high (MSI-H) is when two or more of the markers are identified. MSI low (MSI-L) is when one marker is identified and MSS stable (MSS) when no marker can be found. The gradings MSI-L and MSS are seen as one group. No clinical study has evaluated these two gradings separately. The other method consists of immunohistochemistry where monoclonal antibodies are used against four targeted proteins. Today, immunohistochemistry is used more often and on larger patient groups, due to lower costs and simpler procedures.
The aim of this study is to evaluate the prognostic significance of MSI-H among patients with stage II colorectal cancer and to evaluate the response of preoperative radio- and chemotherapy depending on MSI status. We also want to investigate whether MSI status: is affected by factors such as gender and age, affects the histology of the tumour, gives more lymphatic and vascular incision, increase the risk of emergency surgery and affects the number of lymph nodes that can be examined. These factors largely affect the patient’s expected survival. Both PCR and immunohistochemistry will be used for comparing which method is most efficient for clinical use.
We hope this study will help us identifying subgroups where adjuvant radio- and chemotherapy don’t affect the survival rate, and through this decrease side effects as well as treatment cost.
Perianal abscess
Does ultrasound guidance during draining of abscesses decrease the risk of incontinence and fistula?
Draining of abscesses in the rectum (perianal abscesses) is a well-established treatment. Traditionally, this has been performed during anaesthesia; the swelling is localized and emptied trough an incision. Many of the patients who have experienced this treatment, though, develop chronic fistulas, which can cause long term difficulties with pus. In addition to this, in many cases the sphincter is injured, which might cause incontinence.
Through ultrasound guidance, the abscess can be opened during more controlled circumstances. This technique is relatively new and has yet to be evaluated in larger studies. The goal remains the same – draining the abscess so that the infection can heal. The difference is, that draining with ultrasound guidance can be done while also having a full overview over the location of the abscess in relation to the muscle. In addition to minimizing the risk of fistulas, draining through ultrasound could decrease the risk of sphincter injuries, and consequently also the risk of incontinence. Our study aims to investigate this.
PROSECO
Prospective randomised study of endoscopic fascia closure and long-term outcome
According to the literature, ventral hernia follows at least 10 % of all laparotomies (abdominal incisions). The majority of these ventral hernias need surgery. Traditionally, this has been done through open surgery. The laparoscopic technique is a growing trend within the field, and some profits have been demonstrated in comparative studies between open and laparoscopic technique; during laparoscopy there’s above all a decrease in wound complications, as well as a minimizing of superficial infections.
The overall aim of the study is to scientifically evaluate the technique, and to build a safe base for the introduction and use of laparoscopic technique during surgical repair of ventral hernia. PROSECO is a randomised, controlled multicentre study regarding suture or no suture of abdominal wall defects during laparoscopic ventral hernia repair.
Stomas in rural areas
Facilitating and improving the care of stoma patients in rural areas
Every year, approximately 2000 patients get diagnosed with cancer in the rectum. More than 50 % of these patients need a stoma once the tumour has been surgically removed. Stomas are also constructed following surgery for colon cancer, inflammatory bowel disease and other intestinal diseases. This adds up to around 2000 new stomas in Sweden every year.
More than half of the patients receiving a stoma, or going through a stoma closure, experience some kind of complication, most commonly hernia or dents in adherence to the stoma.
The diagnostics regarding stoma related problems are performed through manual examination, as well as computed tomography and ultrasound inside the stoma. The diagnostics of hernia related to the stoma have been eagerly debated during the last decade, and the diagnostics have to be judged as difficult. Since specialist competence within stoma related problems mainly is located at university hospitals or county hospitals, there is reason to believe that there in rural areas might be a significant number of unrecorded patients with stoma problems.
The long-term goal with this project is to facilitate and improve the care for patients with stomas in rural areas. This will happen through developing a method for examining stomas by distance technology, to avoid for the patient to travel long distances, and also through improving the care events for the post-surgical care following stoma surgery.
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