TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

NCT ID: NCT03536988

Last Updated: 2018-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ulcerative Colitis Postoperative Complications Ileal Pouch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAMIS-IPAA

In TAMIS-IPAA group, transanal minimally invasive surgery of proctectomy with IPAA will be performed.

Group Type EXPERIMENTAL

TAMIS-IPAA

Intervention Type PROCEDURE

In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.

Lap-IPAA

In Lap-IPAA group, transabdominal minimally invasive surgery of proctectomy with IPAA will be performed.

Group Type ACTIVE_COMPARATOR

Lap-IPAA

Intervention Type PROCEDURE

In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Interventions

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TAMIS-IPAA

In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.

Intervention Type PROCEDURE

Lap-IPAA

In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Jianfeng Gong

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianfeng Gong

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, China

Locations

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Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianfeng Gong, MD

Role: CONTACT

+86-25-80860036

Facility Contacts

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Jianfeng Gong, MD

Role: primary

+86-25-80860036

Other Identifiers

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JinlingH TAMIS

Identifier Type: -

Identifier Source: org_study_id

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