TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

May 15, 2018 updated by: Jianfeng Gong, Jinling Hospital, China

Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial

The objective of this RCT is to compare the postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Theoritically, the advantge of TAMIS surgery over traditional trans-abdominal IPAA surgery incudes shorter operation time due to simulatous surgery transanlly and transabdominally, reduced operative difficulty in narrow male pelvis, less retained rectal cuff and less "dog-ear" formation. However, its adgange has not been proven in prospecitve randomized trials. The aim of current study is to compare the short and long-term postoperative outcome of transanal versus transabdominal minimally invasive proctectomy with ileal pouch-annal anastomosis in patients with ulcerative colitis.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clincially and pathologically proven ulcerative colitis
  • Aged 18-75 years
  • Patients who will undergo proctectomy and IPAA surgery, incuding the first stage of two-stage surgery, or the second stage of three-stage or modified two-stage surgery
  • Elective surgery
  • Informed constent obtained.

Exclusion Criteria:

  • A contraindication for minimally invasive surgery or TAMIS surgery
  • Ileus or peritonitis
  • Previous surgery in rectum
  • Pregnancy
  • Carcinogenesis of rectum, dysplasia or stricture of ATZ, or planned mucosectomy
  • Patients with planned permnant ileostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAMIS-IPAA
In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.
Procedure: TAMIS-IPAA
In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
Active Comparator: Lap-IPAA
In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.
Procedure: Lap-IPAA
In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: Day 30
Postoperative complcations were documented using comprehensive complication index(CCI)
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cost of treatment
Time Frame: up to 1 year
In Chinese Yuan (CNY)
up to 1 year
Duration of operation
Time Frame: 24 Hr
The duration of operation will be documented in minutes, from skin incision to dress coverage
24 Hr
The incidence of pouch extension
Time Frame: 24 Hr
the need to extend the length of pouch during operation
24 Hr
Intraoperative complications
Time Frame: 24 Hr
Including anastomotic burst, iatrogenic injury
24 Hr
Estimated blood loss
Time Frame: 24 Hr
in mLs during surgery
24 Hr
Postoperative anastmotic leakage
Time Frame: Day 90
Anastomotic leakage was defined as any defect at the anastomotic site confirmed by imaging or during surgical re-intervention, and was categorised according to the impact on clinical management [A, B, C]. Grade A leaks had minimal to no clinical impact on the patient's postoperative course, requiring antibiotics at the most. Grade B leaks required active intervention such as radiological placement of a pelvic drain or transanal lavage. Grade C leaks required re-operation, mostly because the patient was not defunctioned.
Day 90
Time to GI-2 recovery
Time Frame: Day 90
Time to GI-2 recovery, a composite end point of the later of upper (first toleration of solid food) and lower (first bowel movement) GI function.
Day 90
Postoperative length of hospital stay
Time Frame: Day 90
in days
Day 90
Remaining length of anal mucosa.
Time Frame: 24 Hr
The mean lenght of four quadrant during pouchoscopy 2 months after opertion, the length was calculated from the dental line to the anastomotic site.
24 Hr
The incidence of cuffitis and pouchitis
Time Frame: up to 1 year
Pouchitis is defined as inflammatory condition of the ileal pouch reservoir, while cuffitis is defined as the inflammatory condition of the remnant rectal cuff.
up to 1 year
Postoperative quality of life
Time Frame: up to 1 year
Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Jianfeng Gong, Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2018

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JinlingH TAMIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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