Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604730
Status:
RECRUITING
Last Update Posted:
2022-05-11
First Post:
2020-10-15
Brief Title:
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Role of Protective Stoma After Primary Anastomosis for Generalized Peritonitis Due to Perforated Diverticulitis a Prospective Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVERTI 2
Brief Summary:
This study is designed to be a multicentre prospective comparative randomised trial evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis Results will be analysed according to an intention to treat principle after selection and patient consent Immediately before surgery the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique In the control arm a protective stoma will be performed at the end of surgery A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis Stoma reversal will be performed with a trephine incision
Post-stoma closure follow-ups will be planned and all morbiditymortality will be recorded All patients will be examined at 6 12 and 24 weeks after the initial surgery in the surgical department where they were operated a final study visit will be carried out 12 months evaluation of primary endpoint after surgery The parameters explored at medical examinations will be Occurrence of complications Quality of life assessment
Post-stoma closure follow-ups will be planned and all morbiditymortality will be recorded All patients will be examined at 6 12 and 24 weeks after the initial surgery in the surgical department where they were operated a final study visit will be carried out 12 months evaluation of primary endpoint after surgery The parameters explored at medical examinations will be Occurrence of complications Quality of life assessment
Detailed Description:
This study is designed to be a multicentre prospective comparative randomised trial evaluating the efficacy of two surgical strategies for the treatment of generalised peritonitis due to perforated diverticulitis Results will be analysed according to an intention to treat principle The diagnosis will be established by the surgeon investigator on clinical data imagery and operative findings during a laparotomy or laparoscopy After selection and patient consent and immediately before surgery the patient will be randomly assigned to sigmoidectomy with primary anastomosis or to sigmoidectomy with primary anastomosis and diverting stoma Sigmoidectomy will be performed through a midline laparotomy or laparoscopically according to the standard technique with lateral to medial mobilisation of the left colon mobilisation of splenic flexure and identification of left ureter The rectosigmoid junction will be exposed and transected with a stapler Proximal section will be performed on a healthy colonic segment The anastomosis will be performed according to the surgeon investigators preference mechanical or manual anastomosis end to end or side to end
Decisions to clean the colon intraoperatively and to place a drain will be left to the surgeons discretion In the control arm a protective stoma will be performed at the end of surgery A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis Stoma reversal will be performed with a trephine incision
Post-stoma closure follow-ups will be planned and all morbiditymortality will be recorded All patients will be examined at 6 12 and 24 weeks after the initial surgery in the surgical department where they were operated a final study visit will be carried out 12 months evaluation of primary endpoint after surgery The parameters explored at medical examinations will be Occurrence of complications Quality of life assessment
Decisions to clean the colon intraoperatively and to place a drain will be left to the surgeons discretion In the control arm a protective stoma will be performed at the end of surgery A stoma reversal operation will be performed at least 3 months after the first operation and after performing a cologram by water soluble contrast between 4 and 8 weeks to check for the absence of fistula or stenosis at the level of the anastomosis Stoma reversal will be performed with a trephine incision
Post-stoma closure follow-ups will be planned and all morbiditymortality will be recorded All patients will be examined at 6 12 and 24 weeks after the initial surgery in the surgical department where they were operated a final study visit will be carried out 12 months evaluation of primary endpoint after surgery The parameters explored at medical examinations will be Occurrence of complications Quality of life assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None