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TAMIS-IPAA vs. Lap-IPAA for Ulcerative Colitiis

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ClinicalTrials.gov Identifier: NCT03536988
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Postoperative Complications Ileal Pouch Procedure: TAMIS-IPAA Procedure: Lap-IPAA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transanal Versus Transabdominal Minimally Invasive Proctectomy With Ileal Pouch-annal Anastomosis On Postoperative Outcomes in Ulcerative Colitis: a Randomized Controlled Trial
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Postoperative Complications [ Time Frame: Day 30 ]
    Postoperative complcations were documented using comprehensive complication index(CCI)


Secondary Outcome Measures :
  1. Duration of operation [ Time Frame: 24 Hr ]
    The duration of operation will be documented in minutes, from skin incision to dress coverage

  2. The incidence of pouch extension [ Time Frame: 24 Hr ]
    the need to extend the length of pouch during operation

  3. Intraoperative complications [ Time Frame: 24 Hr ]
    Including anastomotic burst, iatrogenic injury

  4. Estimated blood loss [ Time Frame: 24 Hr ]
    in mLs during surgery

  5. 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.

  6. 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.

  7. Postoperative length of hospital stay [ Time Frame: Day 90 ]
    in days

  8. Overall cost of treatment [ Time Frame: up to 1 year ]
    In Chinese Yuan (CNY)

  9. 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.

  10. 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.

  11. Postoperative quality of life [ Time Frame: up to 1 year ]
    Postoperative quality of life(QoL) is determined using Inflammatory Bowel Disease-Questionaire(IBD-Q)



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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
Criteria

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

Information from the National Library of Medicine

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): NCT03536988


Contacts
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Contact: Jianfeng Gong, MD +86-25-80860036 gongjianfeng@hotmail.com

Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jianfeng Gong, MD    +86-25-80860036    gongjianfeng@aliyun.com   
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Principal Investigator: Jianfeng Gong Jinling Hospital, China

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Responsible Party: Jianfeng Gong, associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03536988     History of Changes
Other Study ID Numbers: JinlingH TAMIS
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Ulcerative Colitiis
Ileal pouch anal anastomosis
Transanal Minimally Invasive Surgery
Postoperative Outcome

Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Postoperative Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases