Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
NCT ID: NCT06061432
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2023-12-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* is the endoscopic restore the gastrointestinal continuity procedure effective?
* is this endoscopic procedure safe?
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Previous methods for restoring gastrointestinal continuity after Hartmann's procedure required extensive surgery. The first stage of surgery involves the dissection of adhesions after the previous resection. It is usually the most technically difficult stage of the procedure because of the emergency nature of the primary surgery (obstruction/peritonitis). Once the intestinal adhesions are removed, the colostomy is dissected from the wall, and the descending and sigmoid colons are mobilized. This is most often associated with the need to release splenic flexure. The next step is to identify and mobilize the rectal stump. This is necessary for a safe intestinal anastomosis, which is most often performed using a circular stapler. If a long rectal stump remains after the primary surgery, insertion of the stapler into its terminal segment is sometimes difficult and involves dissection and cutting of the pelvic peritoneum. Restoring gastrointestinal continuity after Hartmann's surgery is technically difficult and carries a high risk of intra- and perioperative complications, with the most common being small/large intestinal injury during adhesion dissection, intraoperative bleeding, ureteral/bladder injury, and splenic injury (most often, the splenic flexure needs to be released). No technical possibility of reconstruction is common (displacement of the rectal stump deep inside the pelvis and shortening of the mesentery of the left half of the colon). The risk of complications related to the restoration of gastrointestinal continuity after Hartmann's surgery is 30-60%; thus, a significant number of patients do not consent to this procedure.
The endoHARP procedure proposed in this article allows easier restoration of gastrointestinal continuity owing to the combination of classic colorectal surgical techniques with endosonography techniques. The technical details of the procedure are described later in this article. To ensure the feasibility of the endoHARP procedure, it is necessary to slightly modify the primary resection procedure using Hartmann's method. After the resection stage, which does not differ from the original surgery, the remaining parts of the sigmoid and descending colon should be mobilized at the promontorium level. This allows fixation of the closed rectal stump. Side-to-end anastomosis of the intestine to the rectal stump was performed using four 3-0 absorbable sutures. The end of the sigmoid colon is typically brought out into the left middle abdomen. However, this procedure may not be feasible for all patients. It is not possible to use this modification in most cases involving a short segment of the remaining left half of the colon, those with inflammatory infiltration within the mesentery, or those requiring anterior rectal resection (low-sigmoid tumors). However, this modification is technically feasible in a considerable number of patients undergoing Hartmann's procedure.
The steps of the modified Hartmann's sigmoid resection procedure are summarized below.
1. Resection of the sigmoid colon performed as in the original method
2. Mobilization of the remaining part of the sigmoid and descending colon
3. Possible mobilization of the splenic flexure
4. Fixation of the descending and sigmoid colon to the rectal stump with four 3-0 serous sutures
Endoscopic ultrasound (EUS)-guided restoration of gastrointestinal continuity At least 12 weeks (ranging from 3 to 6 months) should elapse between the formation of the colostomy and its closure (i.e., restoration of gastrointestinal continuity). The classic method for the restoration of gastrointestinal continuity involves opening the abdominal cavity, dissection of the intestinal stump and stoma and its closure, enteroenteric anastomosis with manual or mechanical sutures, and closure of the abdominal cavity. However, during the restoration of gastrointestinal continuity after opening the abdominal cavity, the surgeon usually finds numerous adhesions from the previous surgery, which technically impedes the procedure and requires careful dissection to avoid iatrogenic intestinal perforation. In some cases, anatomical conditions encountered after opening the abdominal cavity prevent surgery. The patient is then destined to have a permanent stoma because the restoration of gastrointestinal continuity is technically impossible. In addition, surgical procedures to restore gastrointestinal continuity are associated with the risk of enteroenteric anastomotic leakage.
Recent developments in interventional endoscopy of the gastrointestinal tract and the therapeutic use of EUS have enabled endoscopic gastrointestinal anastomoses using transmural self-expandable prostheses to restore gastrointestinal continuity in patients with high gastrointestinal obstruction. During EUS-guided gastroenterostomy, the gastric lumen is anastomosed to the small intestinal lumen (gastrointestinal anastomosis). Endoscopic anastomosis of the stomach to the small intestine in patients with high gastrointestinal obstruction is performed by inserting a self-expandable metal transmural endoprosthesis (20 mm in diameter and 10 mm in length) using electrocautery under endoscopic, fluoroscopic, and endosonography guidance. A similar approach will be used in our EndoHARP technique 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. In addition, a contrast agent administered through colostomy will fill the intestinal loop which will be visible on both EUS and fluoroscopy, improving visibility during endoscopic surgery. 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.
After endoscopic surgery, the patients will undergo a gastrointestinal passage examination with a contrast agent for four weeks. If the patency of the endoscopic enterorectal anastomosis is confirmed radiologically, the patient will be eligible for colostomy closure in a traditional surgical procedure (i.e., cutting and closing the colostomy with a linear stapler, returning it to the abdominal cavity without the need for intestinal dissection, removal of peritoneal adhesions, and most importantly, for intestinal anastomosis). Thus, the risks of intestinal anastomotic leakage and iatrogenic intestinal perforation during dissection are avoided, thereby increasing the safety of the procedure. Then, the skin area after colostomy will be closed in layers. The metal endoprosthesis will be simultaneously removed from the enterorectal anastomosis during the surgical closure of the colostomy. At this point, the interventional treatment is completed, and gastrointestinal continuity is permanently restored.
The patient will be followed up periodically in the Surgical Clinic every 3 months for the first 12 months after surgery and every 6 months for the next 4 years. Follow-up endoscopic examinations of the lower gastrointestinal tract with evaluation of enterorectal anastomosis will be scheduled every 3-6-12 months, and then every 3 years for the next 9 years.
Number of participants necessary to demonstrate an effect is 100.
The stages of EUS-guided restoration of gastrointestinal continuity are summarized below.
THE FIRST STAGE of endoscopic restoration of gastrointestinal continuity
1. Administration of a contrast agent through the stoma to the intestinal loop
2. Insertion of the echoendoscope into the rectal/colon stump and identification of fixed and contrast-filled large/small intestinal loops on EUS
3. Performance of EUS-guided enterorectal/enteroenteric anastomosis using a set for inserting a self-expandable metal transmural endoprosthesis with electrocautery
1. performance of a transmural/transrectal puncture using electrocautery
2. expansion of the transmural endoprosthesis through the puncture site
3. contrast administration through anastomosis to confirm the tightness of enterorectal/enteroenteric anastomosis
4. Extend the transmural endoprosthesis lumen with a high-pressure balloon up to 20 mm in diameter.
THE SECOND STAGE (after four weeks) of endoscopic restoration of gastrointestinal continuity
One surgical team
1. Circular incision around the stoma
2. Closure of colostomy with a linear stapler
3. Return of the closed intestinal loop into the abdominal cavity
4. Skin closure
Simultaneously - second surgical team (endoscopic)
1. Insertion of the endoscope into the rectum
2. Seizure of the transmural endoprosthesis with endoscopic forceps
3. Removal of the endoprosthesis
4. Endoscopic and fluoroscopic follow-up of endoscopic intestinal anastomosis
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Endoscopic Ultrasound- Guided Hartmann Reversal Procedure
Participants after Hartmann procedure, who were qualified and underwent Endoscopic Ultrasound- Guided Hartmann Reversal Procedure.
Endoscopic restoration of gastrointestinal continuity after Hartmann 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopic restoration of gastrointestinal continuity after Hartmann 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Łódź
OTHER
Nicolaus Copernicus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mateusz Jagielski
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mateusz Jagielski, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of General, Gastroenterological and Oncological Surgery, Collegium Medicum, Nicolaus Copernicus University in Toruń, Poland
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bakker FC, Hoitsma HF, Den Otter G. The Hartmann procedure. Br J Surg. 1982 Oct;69(10):580-2. doi: 10.1002/bjs.1800691007.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DGGOS/MJ/1/2023
Identifier Type: -
Identifier Source: org_study_id