Clinical Trials Logo

Clinical Trial Summary

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.


Clinical Trial Description

CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method. Firstly, the cap added to the front of colonoscope can fully expose the operating field. Secondly, before or during the opportunity of CAES, endoscopist can perform endoscopic differentiation diagnosis (such as tumors, inflammatory bowel disease and others induced hematochezia), endoscopic therapy within lower-gut based on the same colon preparation, thus saving patients' medical cost, physical and mental pain. The last but not least, specially designed length of endoscopic injection needle (eg.10-20 mm) was used in CAES could be helpful for accurately controlling the injection angle, direction, depth under direct vision and to avoid iatrogenic injury due to ectopic injection.The core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy, reduce the iatrogenic injuries, avoid pain during and after therapy. Our pilot studies demonstrated that CAES based on long injection needle is an effective, safe, convenient operation technique. 100% of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up, with no severe or obvious complications related to CAES. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04169152
Study type Observational
Source The Second Hospital of Nanjing Medical University
Contact Faming Zhang, MD,PhD
Phone 02558509884
Email fzhang@njmu.edu.cn
Status Recruiting
Phase
Start date December 30, 2019
Completion date June 30, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Completed NCT00946205 - Laparoscopic Rectopexy for Rectal Prolapse N/A
Not yet recruiting NCT06455501 - FOAM: Functional Outcome After Ventral Mesh Rectopexy
Completed NCT02609555 - TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse N/A
Recruiting NCT01880918 - A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing N/A
Completed NCT01056913 - NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery Phase 4
Completed NCT06353230 - Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children N/A
Completed NCT05254860 - Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse N/A
Recruiting NCT01992406 - Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection N/A
Active, not recruiting NCT06330857 - Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy N/A
Completed NCT01980043 - Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse N/A
Completed NCT03643393 - Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure N/A
Completed NCT04627610 - Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele
Terminated NCT04893642 - Swedish Rectal Prolapse Trial N/A
Recruiting NCT04817150 - 3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study N/A
Enrolling by invitation NCT05728554 - Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
Recruiting NCT03917056 - Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse N/A
Completed NCT02971332 - Long Term Results of STARR With Contour Transtar N/A
Active, not recruiting NCT04013152 - Clinical Database of Colorectal Robotic Surgery
Recruiting NCT06245577 - Biological Mesh Versus Synthetic Mesh in Interdisciplinary RRP With SCP N/A