Clinical trial · Interventional
Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
Endoscopic Reconstruction of the Gastrointestinal Tract After Surgical Resection Procedures Within the Large Intestine (Hartmann's Procedure- Modification of the Method Facilitating the Restoration of Gastrointestinal Continuity)
NCT06061432CI-TRIAL-00070057EndoHARPnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Diverticular Diseases | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic restoration of gastrointestinal continuity after Hartmann procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
- description
- Participants after Hartmann procedure, who were qualified and underwent Endoscopic Ultrasound- Guided Hartmann Reversal Procedure.
- interventionNames
- Procedure: Endoscopic restoration of gastrointestinal continuity after Hartmann procedure
Primary outcomes (2)
- measure
- Rate of efficacy of endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore the gastrointestinal continuity in patients after Hartmann procedure (Endo-HARP)
- timeFrame
- 12 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (11)
- BACKGROUNDZaimi 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
- BACKGROUNDBakker 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
- BACKGROUNDHallam 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
- BACKGROUNDMirnezami 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
- BACKGROUNDZarnescu 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
- BACKGROUNDTsalikidis 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
- BACKGROUNDJaruvongvanich 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.