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Stoma IleostomyNCT05753709

Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study

A study testing Hand sewn end-to-end anastomosis, Hand sewn side-to-side anastomosis and Stapled side-to-side anastomosis in people with Stoma Ileostomy and Stoma Colostomy, run by Sawai Mansingh Medical College at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). Read more about this study

Who is it for?
Any age
Conditions the study is for
Stoma Ileostomy, Stoma Colostomy, Anastomosis
What is being tested?
Hand sewn end-to-end anastomosis, Hand sewn side-to-side anastomosis and Stapled side-to-side anastomosis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteIndia
Study dates
1 Jan 2022to 30 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible participants were all the patients admitted in general surgical wards of SMS Hospital, Jaipur, for stoma reversal, after taking written informed consent

Who cannot join

  • Pre-operatively diagnosed malnutrition or cachexia
  • Bleeding disorders
  • Patients undergoing stoma reversal along with a concurrent abdominal surgery
  • Rectal anastomosis
  • Use of circular stapler for anastomosis.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Sawai Mansingh Medical College and Hospital

    Jaipur, Rajasthan, 302004

Other trials in India

About this study

Official title: Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Randomised Clinical Trial

The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is:

  • If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity.
Read more

Participants admitted for stoma reversal will be divided into two groups:

  1. EE: Conventional Hand-sewn end-to-end anastomosis, and
  2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups:
  3. HSSA: Hand-sewn side-to-side anastomosis
  4. SSSA: Stapled side-to-side anastomosis

Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see:

  1. Rates of major post-operative complications
  2. Rates of short-term complications (within 30 days of surgery)
  3. Rates of re-operation
  4. Post-operative length of stay in the hospital
Being tested
Hand sewn end-to-end anastomosis, Hand sewn side-to-side anastomosis, Stapled side-to-side anastomosis
Medical subject headings
Ileus, Anastomotic Leak, Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand sewn end-to-end anastomosisProcedure or surgery

    Hand sewn end-to-end anastomosis (EE) Holding sutures were taken through a seromuscular bite with PDS (Polydiaxonone) 3-0 or Silk 2-0 RB (Round Bodied needle), one each at the mesenteric and antimesenteric ends of the stoma. A posterior layer of Lembert sutures was taken first. The first bite was taken at the anti-mesenteric end and a knot was applied. A Connell stitch was applied at the corner and then the posterior layer was closed using an inverting interlocking continuous stitch till the mesenteric end. Another Connell stitch was applied here to secure the corner and the suture was continued on to the anterior layer which was then closed in a similar manner using a continuous interlocking stitch. The final bite crossed the initial knot and the final knot was applied. An anterior layer of Lembert sutures was taken to reinforce the anastomotic line.

  • Hand sewn side-to-side anastomosisProcedure or surgery

    Hand sewn side-to-side anastomosis (HSSA) Each end of the stoma was closed using either a single layer of inverting interlocking continuous sutures with PDS 3-0 or Silk 2-0 RB, or a Linear Stapling device. The two closed stumps were then brought adjacent to each other in an anti-peristaltic arrangement. A posterior layer of Lembert sutures was applied using Silk 2-0 RB. The bowel wall was incised using electrocautery close to the suture line. The incision was lengthened up to a width of at least 5-6 cm. The posterior and anterior layer was now closed using the same technique as in HS using PDS 3-0. An anterior layer of Lembert sutures was applied. The mesenteric defect was then closed using a superficial interrupted layer of Silk 2-0 RB.

  • Stapled side-to-side anastomosisProcedure or surgery

    Stapled side-to-side anastomosis or Functional End-to-end anastomosis (SSSA/FEEA) The two limbs of a Linear Cutter SR55 are placed into the proximal and distal bowel loops of the stoma, facing as far away from the mesenteric border as possible and then fired. If both lumens are of similar size, traction sutures are applied with Silk 2-0 RB at the anterior and posterior termination ends of the staple line. The two ends are pulled away from each other, and a Linear Cutter SR75 is applied just below the edge of the bowel and fired. However, in case of an ileo-colostomy, after the first linear cutter SR55 is fired, the two suture lines are approximated in such a way that they do not get apposed but rather lie adjacent to each other. The lumen is then clamped in SR75 which is then fired.

Study groups in NCT05753709
Study groupRoleWhat they receive
EEActive comparatorEnd-to-end anastomosis, done in a conventionally described hand-sewn technique using sutures
Receives: Procedure: Hand sewn end-to-end anastomosis
SSSAActive comparatorStapled side-to-side anastomosis of the stoma using a linear cutter stapling device
Receives: Procedure: Stapled side-to-side anastomosis
HSSAActive comparatorHand-sewn anastomosis of the stoma using suturing of bowel loops placed in a side to side orientation
Receives: Procedure: Hand sewn side-to-side anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Post-operative Ileus (POI)

    Number of participants with two or more episodes of nausea/vomiting, inability to tolerate oral diet over 24 hours, absence of flatus over 24 hours, or distension, and with radiologic confirmation, occurring postoperatively without spontaneous resolution

    Measured: From the day of surgery for 30 days

  2. Number of participants with Anastomotic Leak

    Number of participants with leakage of bowel contents from the anastomotic site, confirmed with imaging studies and clinical signs, such as fever >38.5˚C, leucocytosis, elevated serum C-reactive protein, drainage of intestinal content from the drain or computed tomography findings of abscess formation around the anastomosis.

    Measured: From the day of surgery for 30 days

  3. Number of participants with complications of Clavien-Dindo grade higher than 2

    Number of participants with complications developing post-operatively of Clavien-Dindo grade higher than 2, suggestive of a severe complication.

    Measured: From the day of surgery for 30 days

  4. Number of participants with Bowel Obstruction

    Number of participants with Bowel dilatation and obstipation (inability to pass flatus as well as motion), requiring surgery for treatment, with transition point of the obstruction confirmed either radiologically or intraoperatively

    Measured: From the day of surgery for 30 days

Secondary outcomes (8)

  1. Operating Time

    Time during surgery from incision to skin closure

    Measured: Intraoperatively

  2. Number of participants with Wound Infection

    Number of participants with Infection of the incision site ranging from simple local purulent collection to overt infection requiring re-operation

    Measured: From the day of surgery for 30 days

  3. Number of participants with Anastomotic Bleeding

    Number of participants with Evidence of bleeding around the anastomotic site, confirmed by a complaint of melena, or radiological or endoscopic findings.

    Measured: From the day of surgery for 30 days

  4. Number of participants with Anastomotic Stricture

    Number of participants with Imaging studies done in patients with complaints of nausea or bloating after oral intake, demonstrating intestinal distension starting from oral side of the anastomotic site, occurring due to narrowing at the site of anastomosis due to any cause. This did not include patients unable to pass flatus and motion (obstipation, criteria for bowel obstruction) or patients only unable to tolerate oral diet without other symptoms (criteria for POI).

    Measured: From the day of surgery for 30 days

  5. Number of participants with Intra-abdominal Collection

    Number of participants with fluid collection inside the abdominal cavity developing post-operatively, of any origin, which was not present before surgery. The fluid collection includes presence of ascitic fluid, blood or pus, in amount sufficient to be detected by an abdominal ultrasound or computed tomography imaging. The number of participants showing presence of fluid was measured, and not the volume of fluid.

    Measured: From the day of surgery for 30 days

  6. Number of participants with Re-operation

    Number of participants developing complications severe enough and not responding to medical management, that needed to be re-operated

    Measured: From the day of surgery for 30 days

  7. Number of participants with Organ Dysfunction for each individual organ

    Number of participants with Dysfunction in any organ, evidenced by symptoms and blood tests, developing post-operatively and not present before surgery. The outcome was measured as the number of participants developing dysfunction of each a particular organ system, labelled as Renal, Cardiac, Hepatic, Vascular and Respiratory.

    Measured: From the day of surgery for 30 days

  8. Overall Morbidity

    The overall morbidity is reflective of the number of patients who have at least 1 complication; that is, patients who have at least 1 complication were counted only once, and only their highest-grade complication was counted, graded on the Clavien-Dindo scale.

    Measured: From the day of surgery for 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start1 Jan 2022
  3. Primary completion5 Oct 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two groups in parallel: EE and SS, and another comparison with three arms: EE versus SS divided into two separate arms: SSSA and HSSA
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753709
Sponsor's protocol ID
37/MC/EC/2021
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stedman's Medical Dictionary. 27th ed. Baltimore: Lippincott Williams & Wilkins; 2000.

  • Turnbull RB, Weakley FL. St Louis: Mosby. Atlas of intestinal stomas. 1967;32-9.

  • Dinc B, Ay N, Ciyiltepe H. Comparing methods of ileostomy closure constructed in colorectal surgery in Turkey. Prz Gastroenterol. 2014;9(5):291-6. doi: 10.5114/pg.2014.46165. Epub 2014 Oct 19.

    PubMed 25396004

  • Prassas D, Ntolia A, Spiekermann JD, Rolfs TM, Schumacher FJ. Reversal of Diverting Loop Ileostomy Using Hand-Sewn Side-to-Side versus End-to-End Anastomosis after Low Anterior Resection for Rectal Cancer: A Single Center Experience. Am Surg. 2018 Nov 1;84(11):1741-1744.

    PubMed 30747626

  • Steichen FM. The use of staplers in anatomical side-to-side and functional end-to-end enteroanastomoses. Surgery. 1968 Nov;64(5):948-53. No abstract available.

    PubMed 5687844

  • Liu Z, Wang G, Yang M, Chen Y, Miao D, Muhammad S, Wang X. Ileocolonic anastomosis after right hemicolectomy for colon cancer: functional end-to-end or end-to-side? World J Surg Oncol. 2014 Oct 7;12:306. doi: 10.1186/1477-7819-12-306.

    PubMed 25287418

  • Sameshima S, Koketsu S, Yoneyama S, Miyato H, Kaji T, Sawada T. Outcome of functional end-to-end anastomosis following right hemicolectomy. Int Surg. 2009 Jul-Sep;94(3):249-53.

    PubMed 20187520

  • Goto T, Kawasaki K, Fujino Y, Kanemitsu K, Kamigaki T, Kuroda D, Suzuki Y, Kuroda Y. Evaluation of the mechanical strength and patency of functional end-to-end anastomoses. Surg Endosc. 2007 Sep;21(9):1508-11. doi: 10.1007/s00464-006-9131-6. Epub 2007 Feb 7.

    PubMed 17285383

  • Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD004320. doi: 10.1002/14651858.CD004320.pub3.

    PubMed 21901690

  • Loffler T, Rossion I, Goossen K, Saure D, Weitz J, Ulrich A, Buchler MW, Diener MK. Hand suture versus stapler for closure of loop ileostomy--a systematic review and meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2015 Feb;400(2):193-205. doi: 10.1007/s00423-014-1265-8. Epub 2014 Dec 25.

    PubMed 25539702

  • 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.

    PubMed 23095628

  • Chassin JL, Rifkind KM, Turner JW. Errors and pitfalls in stapling gastrointestinal tract anastomoses. Surg Clin North Am. 1984 Jun;64(3):441-59. doi: 10.1016/s0039-6109(16)43330-x.

    PubMed 6379923

  • Perez RO, Habr-Gama A, Seid VE, Proscurshim I, Sousa AH Jr, Kiss DR, Linhares M, Sapucahy M, Gama-Rodrigues J. Loop ileostomy morbidity: timing of closure matters. Dis Colon Rectum. 2006 Oct;49(10):1539-45. doi: 10.1007/s10350-006-0645-8.

    PubMed 16897328

  • Flikier-Zelkowicz B, Codina-Cazador A, Farres-Coll R, Olivet-Pujol F, Martin-Grillo A, Pujadas-de Palol M. [Morbidity and mortality associated with diverting ileostomy closures in rectal cancer surgery]. Cir Esp. 2008 Jul;84(1):16-9. doi: 10.1016/s0009-739x(08)70598-0. Spanish.

    PubMed 18590670

  • Hiranyakas A, Rather A, da Silva G, Weiss EG, Wexner SD. Loop ileostomy closure after laparoscopic versus open surgery: is there a difference? Surg Endosc. 2013 Jan;27(1):90-4. doi: 10.1007/s00464-012-2422-1. Epub 2012 Jun 30.

    PubMed 22752281

Questions about this trial

What is this clinical trial studying?

A study testing Hand sewn end-to-end anastomosis, Hand sewn side-to-side anastomosis and Stapled side-to-side anastomosis in people with Stoma Ileostomy and Stoma Colostomy, run by Sawai Mansingh Medical College at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Post-operative Ileus (POI) (time frame: From the day of surgery for 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753709, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

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