Digestive System Diseases

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Rectal Diseases

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Cola

Patients suffering from CRC or gastric cancer scheduled to have surgical resection of colon/rectum or stomach.

Patients suffering from non-malignant disease scheduled to have surgery.

Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.

No intervention will be given to patients.

Tao Fu, MD

The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.

Biospecimens will be analyzed to study, but not limited to, genomics, epigenomics, and proteomics.

Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery

Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.

Renmin Hospital of Wuhan University

Director of Department of GI Surgery II

Adenoma

Fistula

Polyps

Fissure in Ano

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anus Diseases

Pharmaceutical Solutions

Micronutrients

Silicon

In the Intervention group the Coloshield Device (double balloon system) will be introduced at the beginning of surgery followed by a washout of the rectum with 500ml of saline solution. The grade of macroscopic contamination will be assessed.

In the control Group the grade of macroscopic contamination will be assessed after rectal washout with 500ml of saline solution.

Coloshield is designed to occlude the rectum during surgery thus enabling the possibility for rectal washout and maintaining a clear operating field. The rod-shaped Instrument contains two silicon balloons which are inflated by means of a catheter. Several holes at the section in between the two balloons are connected to another catheter, which enable negative pressure to be established. By insufflation of the two balloons and establishment of a negative pressure between the balloons by means of connection to a closed drainage bottle the colon is occluded for the duration of surgery.

Coloshield

In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.

Control

Daniel C Steinemann, MD

In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).

Trial on Use of Coloshield in Transanal and Anal Surgery

Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery

The position of the deployed Coloshield at beginning of surgery and after 30 minutes is measured by rigid rectoscopy in cm from anal verge. Any slippage of the device during surgery is documented.

After removal of Coloshield by rigid rectoscopy any bleedings or tear injuries in the rectal mucosa (caused by Coloshield) are noted. It will be documented if there are bleedings or tear injuries or not, and if the exact number of bleedings and tear injuries.

The pain level on a VAS score from 0 (no pain) to 10 (strongest) 6 hours, 24 hours and 48 hours after surgery are documented.

Daniel Steinemann, MD

Sponsor-Investigator

Infections

Pilonidal Sinus

Abscess

Cysts

Central Nervous System Depressants

Bupivacaine

Methylene Blue

Ultrasound guided bilateral pudendal nerve block

Ultrasound guided Pudendal nerve block

Apurb Sharma, MD

Prajjwal Bhattarai, MD

Saurav Raj Khatiwada, MD

Prajjwal Raj Bhattarai, MD

Pragati Koirala, MD

Study Description:

The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone.

Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups:

1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue.
2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone.

The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue.

Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention.

Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale.

By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.

Study Description:

The aim of this randomized comparative study is to investigate the effectiveness of two different approaches to postoperative analgesia in patients undergoing perianal surgery. The study will compare the use of Bupivacaine alone with Bupivacaine combined with Methylene Blue in a pudendal nerve block.

Perianal surgical procedures, such as abscess drainage, fistulectomy, and hemorrhoidectomy, can cause significant postoperative pain. The goal of this study is to find a more effective and prolonged method of pain relief to improve patient comfort and reduce the need for opioids.

Participants in this study will be individuals scheduled for elective perianal surgery and classified as ASA I and II. They will be randomly assigned to one of two groups:

1. Group A: Participants will receive a pudendal nerve block with Bupivacaine and Methylene Blue.
2. Group B: Participants will receive a pudendal nerve block with Bupivacaine alone.

The pudendal nerve block will be performed under ultrasound guidance at the ischial spine level. The needle will be accurately placed between the Sacro tuberous and sacrospinous ligaments for precise injection of the local anesthetic or the local anesthetic combined with Methylene Blue.

Throughout the study, the researchers will closely monitor the participants to assess the time to the first rescue analgesic and pain levels using the Numeric Rating Scale at specific time intervals (2, 6, 24, 48 hours, and 7 days). Additionally, any side effects, allergies, itching, hematoma, infection, or complications like loss of anal sphincter function will be recorded.

Patient satisfaction will also be evaluated using the Likert scale to determine the perceived effectiveness of the different approaches to postoperative analgesia.

By comparing the outcomes between the two groups, this study aims to determine whether the addition of Methylene Blue to Bupivacaine in a pudendal nerve block can prolong postoperative analgesia in patients undergoing perianal surgery. The findings from this study may contribute valuable insights into improving pain management strategies and enhancing the overall recovery experience for patients undergoing perianal surgical procedures.

Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery

We will compare the time at which patients in either group will demand rescue analgesic

We will ask the patient to select one of the following satisfaction scores:

Very satisfied Moderately satisfied Neither satisfied nor dissatisfied Moderately dissatisfied Very dissatisfied

Numeric Rating Scale (NRS) score for pain intensity will be measured at different time intervals (at 2, 6, 24, 48 hours, and 7 days) after surgery in both study groups.

Incidence of complications related to the pudendal nerve block procedure, such as hematoma, infection, and allergic reactions will be captured when it is detected or at the end of seventh postoperative day

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease	NCT03972956	Colorectal Canc... Gastric Cancer Inflammatory Bo... Gastric Ulcer Hemorrhoids Hernia	No intervention...	18 Years - 80 Years	Renmin Hospital of Wuhan University
Trial on Use of Coloshield in Transanal and Anal Surgery	NCT02579330	Fistula-in-ano Rectal Polyp Rectal Adenoma Hemorrhoids Anal Fissure	Coloshield Control	18 Years -	Cantonal Hosptal, Baselland
Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia	NCT05990569	Hemorrhoids Anal Fissure an... Perianal Absces... Perianal Fistul... Pilonidal Sinus Perianal Skin T...	Ultrasound guid...	15 Years - 90 Years	Nepal Mediciti Hospital

Spots Global Cancer Trial Database for hemorrhoids

Every month we try and update this database with for hemorrhoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hemorrhoids

Every month we try and update this database with for hemorrhoids cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hemorrhoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.