Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease (SuPREMeCD)
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ClinicalTrials.gov Identifier: NCT02631967 |
Recruitment Status :
Recruiting
First Posted : December 16, 2015
Last Update Posted : February 15, 2017
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Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).
This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.
In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.
Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease | Procedure: Kono anastomosis Procedure: Stapled side-to-side anastomosis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial |
Study Start Date : | November 2015 |
Estimated Primary Completion Date : | November 2017 |
Estimated Study Completion Date : | November 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Kono anastomosis
Patients receiving Kono anastomosis
|
Procedure: Kono anastomosis
Kono anastomosis |
Experimental: Stapled side-to-side anastomosis
Patients receiving stapled side-to-side anastomosis
|
Procedure: Stapled side-to-side anastomosis
Stapled side-to-side anastomosis |
- Grade of endoscopic recurrence [ Time Frame: 6 Months ]Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
- Surgical recurrence [ Time Frame: Up to 5 years ]Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
- Endoscopic recurrence [ Time Frame: 6 months up to 5 years ]Presence of endoscopic recurrence
- Grade of endoscopic recurrence [ Time Frame: 6 months up to 5 years ]Severity of endoscopic recurrence at the site of anastomosis
- Clinical recurrence [ Time Frame: Up to 5 years ]Presence of clinical recurrence (according to Crohn's disease activity index)
- Operating time [ Time Frame: Intraoperatively ]Duration of the operation (min)
- Anastomosis time [ Time Frame: Intraoperatively ]Time (min) required to perform the anastomosis
- Anastomotic leak [ Time Frame: Up to 30 days ]Incidence of anastomotic leak
- Surgical re-intervention [ Time Frame: Up to 30 days ]Rate of patients requiring surgical re-intervention
- Postoperative morbidity rate [ Time Frame: Up to 30 days ]Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification
- Recovery times [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Crohn's disease requiring ileocecal resection
Exclusion Criteria:
- age > 75 years
- age < 18 years
- inability to give the consent to the participation in the trial
- refusal to participate in the trial after receiving accurate information

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631967
Contact: Luigi Bucci, Prof | 00390817462850 | luigi.bucci@unina.it |
Italy | |
UOC Colonproctologia Chirurgica - Dipartimento di Medicina Clinica e Chirurgia - Università degli Studi di Napoli Federico II | Recruiting |
Napoli, Italy, 80121 | |
Contact: Luigi Bucci, Prof 00390817462850 luigi.bucci@unina.it | |
Sub-Investigator: Mariano Cesare Giglio, Dr | |
Sub-Investigator: Gaetano Luglio, Dr | |
Sub-Investigator: Fabiana Castiglione, Prof | |
Sub-Investigator: Antonio Rispo, Dr | |
Sub-Investigator: Giovanni Domenico De Palma, Prof |
Principal Investigator: | Luigi Bucci, Prof | Federico II University of Naples |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Luigi Bucci, Professor, Federico II University |
ClinicalTrials.gov Identifier: | NCT02631967 |
Other Study ID Numbers: |
211/15 |
First Posted: | December 16, 2015 Key Record Dates |
Last Update Posted: | February 15, 2017 |
Last Verified: | February 2017 |
Crohn disease ileocecal resection anastomosis Kono |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |