Endoscopic Ultrasound- Guided Hartmann Reversal Procedure

NCT06061432 | Not Yet Recruiting

• 1 other identifier: DGGOS/MJ/1/2023
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn about clinical usefulness endoscopic gastrointestinal anastomoses to restore the gastrointestinal continuity in patients with permanent colostomy after Hartmann procedure. The main questions it aims to answer are:

• is the endoscopic restore the gastrointestinal continuity procedure effective?
• is this endoscopic procedure safe?

Conditions

Colorectal Neoplasms; Diverticular Diseases; Inflammatory Bowel Diseases

Keywords

colorectal surgery; endotherapy; anastomosis; endoscopic ultrasound; gastrointestinal continuity; Hartmann procedure

Outcome Measures

Primary Outcomes (2)

• Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  Evaluation of efficacy based on patency of endoscopic entero-rectal anastomosis confirmed radiologically and endoscopically. Unit of Measure: the number of participants with patency of endoscopic entero-rectal anastomosis compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  12 months

• Rate of complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  Evaluation of all complications in patients with endoscopic gastrointestinal anastomoses (Endo-HARP). Unit of Measure: the number of participants with complications compared to the total number of participants, who underwent endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP).

  12 months

Secondary Outcomes (4)

• Rate of early complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  30 days

• Rate of late complications during endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  12 months

• Rate of technical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  duration of procedure

• Rate of clinical success of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)

  12 months

Study Arms (1)

Endoscopic Ultrasound- Guided Hartmann Reversal Procedure

EXPERIMENTAL

Participants after Hartmann procedure, who were qualified and underwent Endoscopic Ultrasound- Guided Hartmann Reversal Procedure.

Procedure: Endoscopic restoration of gastrointestinal continuity after Hartmann procedure

Interventions

Endoscopic restoration of gastrointestinal continuity after Hartmann procedure PROCEDURE

EndoHARP is a new technique proposed to restore gastrointestinal continuity after the Hartmann's procedure. For EndoHARP, a fixed loop of the large intestine will be identified on endosonography after an echoendoscope is inserted into the rectal stump under endoscopic guidance. Then, using the set for inserting self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) with electrocautery (as in endoscopic gastroenterostomy), EUS-guided anastomosis of the rectal stump to the large intestine loop will be performed, allowing the natural passage of intestinal contents through the endoscopic anastomosis, restoring gastrointestinal continuity. The aim of leaving the self-expandable transmural endoprosthesis in the anastomosis is not only to maintain the patency of the intestinal anastomosis of at least 20 mm in diameter, but also to diminish the risk of endoscopic intestinal anastomotic leak by completely covering the prosthesis with a polymer layer.

Endoscopic Ultrasound- Guided Hartmann Reversal Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants of both sexes aged above 18 years
• participants, who provided informed consent for such treatment
• eligibility for Hartmann's procedure according to current medical knowledge based on evidence-based medicine.

You may not qualify if:

• pregnancy, breastfeeding, or intention to become pregnant during the study
• contraindications to electrosurgical instruments
• allergy to any of the materials used in the study
• participants with advanced cancer in the metastatic stage
• participants ineligible for restoration of gastrointestinal continuity
• participants ineligible for surgery
• participants ineligible for general anesthesia

Sponsors & Collaborators

• Nicolaus Copernicus University: lead
• Medical University of Łódź: collaborator

Related Publications (10)

• Zaimi I, Sparreboom CL, Lingsma HF, Doornebosch PG, Menon AG, Kleinrensink GJ, Jeekel J, Wouters MWJM, Lange JF; Dutch ColoRectal Audit Group. The effect of age on anastomotic leakage in colorectal cancer surgery: A population-based study. J Surg Oncol. 2018 Jul;118(1):113-120. doi: 10.1002/jso.25108. Epub 2018 Jun 7.

  PMID: 29878360 BACKGROUND

• Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. doi: 10.1002/bjs.1800691007.

  PMID: 7127036 BACKGROUND

• Hallam S, Mothe BS, Tirumulaju R. Hartmann's procedure, reversal and rate of stoma-free survival. Ann R Coll Surg Engl. 2018 Apr;100(4):301-307. doi: 10.1308/rcsann.2018.0006. Epub 2018 Feb 27.

  PMID: 29484943 BACKGROUND

• Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.

  PMID: 21394013 BACKGROUND

• Zarnescu EC, Zarnescu NO, Costea R. Updates of Risk Factors for Anastomotic Leakage after Colorectal Surgery. Diagnostics (Basel). 2021 Dec 17;11(12):2382. doi: 10.3390/diagnostics11122382.

  PMID: 34943616 BACKGROUND

• Tsalikidis C, Mitsala A, Mentonis VI, Romanidis K, Pappas-Gogos G, Tsaroucha AK, Pitiakoudis M. Predictive Factors for Anastomotic Leakage Following Colorectal Cancer Surgery: Where Are We and Where Are We Going? Curr Oncol. 2023 Mar 7;30(3):3111-3137. doi: 10.3390/curroncol30030236.

  PMID: 36975449 BACKGROUND

• Jaruvongvanich V, Mahmoud T, Abu Dayyeh BK, Chandrasekhara V, Law R, Storm AC, Levy MJ, Vargas EJ, Marya NB, Abboud DM, Ghazi R, Matar R, Rapaka B, Buttar N, Truty MJ, Aerts M, Messaoudi N, Kunda R. Endoscopic ultrasound-guided gastroenterostomy for the management of gastric outlet obstruction: A large comparative study with long-term follow-up. Endosc Int Open. 2023 Jan 13;11(1):E60-E66. doi: 10.1055/a-1976-2279. eCollection 2023 Jan.

  PMID: 36644538 BACKGROUND

• Mintziras I, Miligkos M, Wachter S, Manoharan J, Bartsch DK. Palliative surgical bypass is superior to palliative endoscopic stenting in patients with malignant gastric outlet obstruction: systematic review and meta-analysis. Surg Endosc. 2019 Oct;33(10):3153-3164. doi: 10.1007/s00464-019-06955-z. Epub 2019 Jul 22.

  PMID: 31332564 BACKGROUND

• Reali C, Landerholm K, George B, Jones O. Hartmann's Reversal: Controversies of a Challenging Operation. Minim Invasive Surg. 2022 Nov 9;2022:7578923. doi: 10.1155/2022/7578923. eCollection 2022.

  PMID: 36406794 BACKGROUND

• Mege D, Manceau G, Beyer-Berjot L, Bridoux V, Lakkis Z, Venara A, Voron T, Brunetti F, Sielezneff I, Karoui M; AFC (French Surgical Association) Working Group. Surgical management of obstructive right-sided colon cancer at a national level results of a multicenter study of the French Surgical Association in 776 patients. Eur J Surg Oncol. 2018 Oct;44(10):1522-1531. doi: 10.1016/j.ejso.2018.06.027. Epub 2018 Jul 6.

  PMID: 30041941 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticular Diseases; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Study Officials

• Mateusz Jagielski, Prof.

  Department of General, Gastroenterological and Oncological Surgery, Collegium Medicum, Nicolaus Copernicus University in Toruń, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Jagielski, Prof.

CONTACT

56 679-31-99; matjagiel@gmail.com

Michał Spychalski, Ass. Prof.

CONTACT

46 875-25-01; mspych80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 29, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share