None listed
Conditions
Brief summary
This study aims to assess whether postoperative anorectal pressures change over time and whether these changes differ according to the type of surgical procedure performed. Who is it for? You may be eligible for this study if you are a male or female aged 18 years or older who are undergoing colorectal surgery with formation of a primary colorectal anastomosis at Gold Coast University Hospital, including anterior resection or Hartmann’s reversal, and who are able to provide informed consent. Study details Those who are eligible will undergo anorectal pressure measurements using a small, single-use THD SensyProbe. Measurements will be taken once before surgery and then daily for up to five days after surgery, or until discharge from hospital if earlier. During each assessment, the probe will be gently inserted into the anal canal while the participant lies on their side, and resting anorectal pressure will be recorded. All participants will receive their planned surgery and standard postoperative care. There is no experimental treatment and no randomisation involved in this study. It is hoped that the findings will improve understanding of bowel function after colorectal surgery and help inform future strategies to reduce complications such as anastomotic leak.
Interventions
Participants undergoing formation of a primary colorectal anastomosis without a defunctioning stoma will undergo serial anorectal manometry measurements using the THD Anopress System and single-use THD SensyProbe. Measurements will be performed once preoperatively (baseline) and then daily on postoperative days 1, 2, 3, 4 and 5, or until hospital discharge if earlier. During each assessment, the lubricated probe will be inserted into the anal canal while the participant is positioned in the left
Participants undergoing formation of a primary colorectal anastomosis without a defunctioning stoma will undergo serial anorectal manometry measurements using the THD Anopress System and single-use THD SensyProbe. Measurements will be performed once preoperatively (baseline) and then daily on postoperative days 1, 2, 3, 4 and 5, or until hospital discharge if earlier. During each assessment, the lubricated probe will be inserted into the anal canal while the participant is positioned in the left lateral position. Resting anorectal pressure (mmHg) will be recorded over a stable 10–20 second period. No experimental treatment, alteration to standard surgical care, or additional therapeutic intervention will be provided as part of the study. Standard perioperative management will proceed according to routine clinical practice. The proceedure and recordings will be conducted by only members of the research group who are all qualified surgeons with a specialist interest in colorectal surgery. All members of the group have undergone stanadardised training for the use of equipment. Data will be recorded on a password protected database (Redcap) and will be monitored by the PI.
Sponsors
Gold Coast Univeristy Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older. Able and willing to provide informed consent. Undergoing formation of a primary end-to-end colorectal anastomosis performed by the colorectal surgery department at Gold Coast University Hospital. Procedures include anterior resection (high or low anterior resection) or Hartmann's reversal. Patients with a history of pelvic radiotherapy are eligible for inclusion
Exclusion criteria
Inability or unwillingness to provide informed consent. Inability to tolerate a preoperative digital rectal examination. Concurrent perianal disease. Defunctioning stoma present or planned. Transanal rectal tube in situ. Coloanal anastomosis. Colonic pouch formation. Development of a major surgical complication during the study period. Any contraindication to anorectal manometry as determined by the investigators.
Outcome results
None listed