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There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:
Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.
All patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.
The stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.
The stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapled anastomosis | Experimental | Stapled anastomosis by the use of commercially available linear stapler device |
|
| Hand-sewn anastomosis | Active Comparator | Hand-sewn by the use of a resorbable monofilament suture |
|
| Abdominal wall mesh closure | Experimental | Closure by the use of a mesh low-weight net device |
|
| Abdominal wall suture closure | Active Comparator | Closure by the use of slowly absorbing monofilament suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stapled or Hand-sewn anastomosis | Procedure | Randomization between stapled or hand-sewn anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with postoperative bowel obstruction | Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray | 30 days |
| Number of participants with postoperative stoma site hernia | Herni postoperatively on the site of previous stoma detected within 2 years | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with postoperative complications | 30 days | |
| Postoperative Hospital stay | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pontus Gustafsson, MD | Contact | +46703272152 | pontus.gustafsson@gotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Ulrik Lindforss, A.P | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Universitetssjukhuset, Östra sjukhuset | Recruiting | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21845418 | Background | Gustavsson K, Gunnarsson U, Jestin P. Postoperative complications after closure of a diverting ileostoma--differences according to closure technique. Int J Colorectal Dis. 2012 Jan;27(1):55-8. doi: 10.1007/s00384-011-1287-4. Epub 2011 Aug 16. | |
| 24033921 | Background | Gong J, Guo Z, Li Y, Gu L, Zhu W, Li J, Li N. Stapled vs hand suture closure of loop ileostomy: a meta-analysis. Colorectal Dis. 2013;15(10):e561-8. doi: 10.1111/codi.12388. |
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| Mesh or suture stoma site closure | Procedure | Randomization between suture or Mesh closure of the stoma site |
|
| Centralsjukhuset Karlstad | Recruiting | Karlstad | Sweden |
|
| Sunderby Sjukhus | Recruiting | Luleå | Sweden |
|
| Lycksele lasarett | Recruiting | Lycksele | Sweden |
| Norrtälje sjukhus | Recruiting | Norrtälje | Sweden |
|
| Östersunds sjukhus | Recruiting | Östersund | Sweden |
|
| Skellefteå lasarett | Recruiting | Skellefteå | Sweden |
|
| Danderyds sjukhus | Recruiting | Stockholm | Sweden |
|
| Karolinska universitetssjukhuset | Recruiting | Stockholm | Sweden |
|
| Norrlands Universitets Sjukhus | Recruiting | Umeå | Sweden |
|
| Region Gotland | Recruiting | Visby | 62149 | Sweden |
|
| 25276286 | Background | Rubio-Perez I, Leon M, Pastor D, Diaz Dominguez J, Cantero R. Increased postoperative complications after protective ileostomy closure delay: An institutional study. World J Gastrointest Surg. 2014 Sep 27;6(9):169-74. doi: 10.4240/wjgs.v6.i9.169. |
| 20372898 | Background | Akiyoshi T, Fujimoto Y, Konishi T, Kuroyanagi H, Ueno M, Oya M, Yamaguchi T. Complications of loop ileostomy closure in patients with rectal tumor. World J Surg. 2010 Aug;34(8):1937-42. doi: 10.1007/s00268-010-0547-8. |
| 19102343 | Background | Chude GG, Rayate NV, Patris V, Koshariya M, Jagad R, Kawamoto J, Lygidakis NJ. Defunctioning loop ileostomy with low anterior resection for distal rectal cancer: should we make an ileostomy as a routine procedure? A prospective randomized study. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1562-7. |
| 23095628 | Background | Loffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Kruger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fusser M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Buchler MW, Weitz J; HASTA Trial Group. HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040). Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D009074 | Melanocyte-Stimulating Hormones |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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