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Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.

ABSTRACT: Background:Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids. Methods:This is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24?weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy. Discussion:The outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique. Trial registration:ClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.

SUBMITTER: Wu X

PROVIDER: S-EPMC7278306 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.

Wu Xia X Wen Quan Q Cui Bota B Liu Yafei Y Zhong Min M Yuan Yu Y Wu Lihao L Zhang Xiaoyin X Hu Yunlian Y Lv Muhan M Wu Qianneng Q He Suyu S Jin Yan Y Tian Shuxin S Wan Rong R Wang Xin X Xu Long L Bai Jianling J Huang Guangming G Ji Guozhong G Zhang Faming F

Therapeutic advances in gastrointestinal endoscopy 20200101

<h4>Background</h4>Cap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to eva ...[more]

PMID: 32551439

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Project description:Video 1Balloon-compression endoscopic injection sclerotherapy for the treatment of esophageal varices. A 50-year-old man with schistosomiasis-induced liver fibrosis presented with melena and hematemesis. The bleeding stopped after intravenous administration of somatostatin and ceftriaxone for 4 days. Balloon-compression endoscopic injection sclerotherapy (bc-EIS) was performed with the patient under general anesthesia to prevent rebleeding. The novel device for bc-EIS is composed of a syringe, a stopcock, a catheter, and an inflatable balloon. In the majority of patients with cirrhosis, the blood flow from the coronary vein drains into the azygos and hemiazygos venous system through esophageal and para-esophageal varices, and eventually back to the inferior vena cava. With compression of proximal esophageal and para-esophageal varices via an inflated balloon, sclerosant can be retained at the injection site, rather than flowing back to the inferior vena cava. Endoscopy revealed the presence of moderately enlarged, beady esophageal varices with red wale signs in the middle and lower esophagus. An inflatable balloon was fixed to an endoscope at a distance of 3 cm from its distal end. When the end of the endoscope was introduced to the target varices, 20 mL of air was injected into the balloon through a thin catheter, making its outer diameter expand to 3.5 cm. A disposable endoscopic injection needle then entered the base of the variceal columns near the cardia. When blood flowed back into the needle, a mixture of Lauromacrogol and methylene blue was intravariceally administered. Minor bleeding at the injection site was stopped through brief compression with the needle sheath. The second injection was performed following the aforementioned procedure. Follow-up endoscopy at 1 month, 4 months, and 7 months revealed the progression from thrombosed blue varices to complete eradication of esophageal varices. Endoscopic ultrasonography also showed the absence of blood flow in the varices after treatment. To date, bc-EIS has been performed successfully on 28 patients with esophageal varices. Variceal eradication was obtained in 17 patients with 1 session, 10 patients with 2 sessions, and 1 patient with 3 sessions. Two patients showed recurrence of esophageal varices on routine follow-up endoscopy and were re-treated with bc-EIS successfully. There were no severe complications during the follow-up period. With the sclerosant retained at injection sites after balloon compression, bc-EIS enables complete eradication of esophageal varices and lowers the risk of recurrence. The blockade of sclerosant also decreases the incidence of complications related to large-volume injection of sclerosant, such as embolization, ulceration, and perforation. In conclusion, bc-EIS appears to be an effective and safe approach for the treatment of esophaeal varices. Further research is underway to determine its suitability for large-scale clinical application.

Project description:Background A novel endoscopic-assisted technique (NET) was created by our team for nipple-sparing mastectomy (NSM) and latissimus dorsi muscle flap (LDMF) reconstruction that enables the procedure to be conducted through a single axillary incision. The authors hypothesized that the NET has the advantages of the traditional ET (TET) and a reduced operation time. The purpose of this study is to compare the advantages and disadvantages of NET, TET and open surgery. Methods A retrospective cohort study was performed on patients who underwent LDMF reconstruction after NSM using open surgery, the TET, or the NET between January 2013 and June 2021. The following outcomes were compared: the operation time, size of the LDMF, the complication rate, hospital length of stay, hospital costs, aesthetic results (the BREAST-Q questionnaire), and quality of life (QoL). The BREAST-Q questionnaire and QoL were underwent preoperatively and 1, 3, and 12 months postoperatively. Results A total of 17 ETs (comprising 10 NETs and 7 TETs) and 28 open surgery procedures were identified and analyzed, the baseline characteristics were comparable in terms of age, body mass index (BMI), tumor location, cup size, and disease stage of the three groups. The mean operation time of the NET group (395.8±176.0 min) in the exploration stage was shorter than that of the TET group (531.6±69.6 min) and equivalent to that of the open surgery group (400.9±67.3 min). The overall postoperative complication rates of the ET and open surgery groups were 35.3% and 60.7%, respectively (P=0.09). The aesthetic results in relation to patients’ satisfaction with their breasts (P=0.001) and backs (P=0.001) were better in the ET group than the open surgery group beginning at 1 month postoperatively. The ET group had better psychosocial well-being beginning at 1 month postoperatively (P=0.002) and sexual well-being beginning at 3 months postoperatively (P<0.001) than the open surgery group. Conclusions LDMF reconstruction after NSM using the ET is associated with lower complication rates, good aesthetic results, and a better QoL than open surgery procedures. The NET is a promising approach, a more convenient procedure, and has a shorter surgery time than TET, however, this conclusion needs to be further validated by randomized clinical trial (RCT) research with a larger sample size.

Dataset Information

Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.

Publications

Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial.

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