Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: Study protocol for a randomized controlled trial (2018)

Type of publication:
Randomised controlled trial

Author(s):
Ugo Grossi, Natasha Stevens, Eleanor McAlees, *Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S. Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H. Knowles, and On behalf of the NIHR CapaCiTY working group

Citation:
Trials; Feb 2018; vol. 19 (no. 1)

Abstract:
Background: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence. Methods: An individual level, stepped-wedge randomised trial has been designed to allow observer-blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate. They will be randomised to three arms with different delays before surgery (0, 12 and 24 weeks). Efficacy outcome data will be collected at equally stepped time points (12, 24, 36 and 48 weeks). The primary objective is to determine clinical efficacy of LVMR compared to controls with reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) at 24 weeks serving as the primary outcome. Secondary objectives are to determine: (1) the clinical effectiveness of LVMR to 48 weeks to a maximum of 72 weeks; (2) pre-operative determinants of outcome; (3) relevant health economics for LVMR; (4) qualitative evaluation of patient and health professional experience of LVMR and (5) 30-day morbidity and mortality rates. Discussion: An individual-level, stepped-wedge, randomised trial serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the waiting-listed participants an opportunity to obtain the intervention at a later date. In keeping with the basic ethical tenets of this design, the average waiting time for LVMR (12 weeks) will be shorter than that for routine services (24 weeks).

Sex differences in the splenic flexure (2017)

Type of publication:
Journal article

Author(s):
Brookes A.F.; Macano C.; Meecham L.; *Stone T.; *Cheetham M.

Citation:
Annals of the Royal College of Surgeons of England; Jul 2017; vol. 99 (no. 6); p. 456-458

Abstract:
INTRODUCTION Anecdotally, surgeons claim splenic flexure mobilisation is more difficult in male patients. There have been no scientific studies to confirm or disprove this hypothesis. The implications in colorectal surgery could be profound. The aim of this study was to assess quantitatively whether there is an anatomical difference in the position of the splenic flexure between men and women using computed tomography (CT). METHODS Portal venous phase CT performed for preoperative assessment of colorectal malignancy was analysed using the hospital picture archiving and communication system. The splenic flexure was compared between men and women using two variables: anatomical height corresponding to the adjacent vertebral level (converted to ordinal values between 1 and 17) and distance from the midline. RESULTS In total, 100 CT images were analysed. Sex distribution was even. The mean ages of the male and female patients were 68.1 years and 66.7 years respectively (p=0.630). The mean vertebral level for men was 8.88, equating to the inferior half of the T11 vertebral body (range: 1-17 [superior half of T9 to inferior half of L2]), and 11.36 for women, equating
to the inferior half of the T12 vertebral body (range: 4-16 [superior half of T10 to superior half of L2]). This difference was statistically significant (p=0.0001) and is equivalent to one whole vertebra. The mean distance from the midline was 160.8mm (range: 124-203mm) for men and 138.2mm (range: 107-185mm) for women (p<0.0001). CONCLUSIONS The splenic flexure is both higher and further from the midline in men than in women. This provides one theory as to why mobilising the splenic flexure may be more difficult in male patients.

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Review of trans anal microscopic surgery in a UK district general hospital- a safe practice with excellent patient outcomes (2017)

Type of publication:
Conference abstract

Author(s):
*V. Vidyaankar, *A. Chakrabarty, *J. McCloud & *R. Clarke

Citation:
Colorectal Disease; Sep 2017; vol. 19 ; Supplement S2 ; p. 123

Abstract:
Aim: Randomised controlled trials have demonstrated advantages of Trans Anal endoscopic microsurgery (TEMS) for the resection of benign and malignant rectal lesions. We assess the safety and outcome of TEMS at a U.K district general hospital. Method: Between July 2011 to January 2017, 122 patients, 54 men and 68 women, Mean age 72 years, underwent TEMS. Patients with Level 4 polyps, large sessile polyps, polyps with invasive features or unsuitable for colonoscopic removal, were selected. Benign follow up with flexible sigmoidoscopy. Cancer follow up with Colonoscopy, MRI, CT, according to protocol. Results: 95 Benign and 27 Cancer lesions. Mean lesion Diameter 46 mm, mean operative time 60 min. Average hospital stay was 1.5 days. Three patients (2.4%) had bleeding, Four (3.2%) perforations, identified and repaired immediately. One (0.8%) surgical emphysema. Four (3.2%) developed pyrexia, two (1.6%) developed minor stricture. One (0.8%) rectovaginal fistula. No recurrence in benign cases. For Early Rectal cancers R0 resection was achieved in 81% and  R1 resection in 19% of cases. One (0.8%) developed local cancer recurrence. No mortality. Conclusion: Our study demonstrates that TEMS can be safely performed at a district general hospital by appropriately trained surgeons, with outcomes comparable with international data.

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Patient and public involvement for a surgical trial in rectal prolapse (2017)

Type of publication:
Conference abstract

Author(s):
Lee M.; Blackwell S.; Brown S.; Sayers A.; Heywood N.; Fearnhead N.; *Lacy-Colson J.; Cornish J.

Citation:
Colorectal Disease; Sep 2017; vol. 19 ; Supplement S2 ; p. 39

Abstract:
Aim: An integral part of trial design is Patient and Public Involvement (PPI) to incorporate patient views and preferences. The aim of this study is to describe the conduct and findings of early PP for a trial in surgical treatment of rectal prolapse. Method: Participants were invited directly by research collaborators and through social media. Only women were invited due to nature of trial. A modified deliberate engagement process was followed. Patients provided expertise on patient experience of the condition, potential recruitment strategies, and outcome measures. Results: 13 patients attended the PPI meeting. Most were recruited by clinicians. Broad representation of age and demographic origin was achieved. Patients agreed with equipoise, and were willing tobe randomised to posterior or ventral rectopexy. Several qualities of life tools were discussed when selecting appropriate outcomes. With respect to sexual function, older patients preferred FSFI and younger patients preferred PISQ-IR. Final consensus was that PISQ-IR was the best compromise for all. Conclusion: Patients with rectal prolapse are willing to engage in PPI for researchers and discuss intimate details on how treatments have affected their personal lives. The PPI exercise confirmed equipoise and modified the outcome measure of sexual function.

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Anatomical siting of the splenic flexure using computed tomography (2017)

Type of publication:
Journal article

Author(s):
*Meecham, L; *Brookes, A; *Macano, Caw; *Stone, T; *Cheetham, M

Citation:
Annals of the Royal College of Surgeons of England; Mar 2017; vol. 99 (no. 3); p. 207-209

Abstract:
INTRODUCTION Often, left-sided colorectal surgery requires splenic flexure mobilisation (SFM) to allow a tension-free anastomosis to be carried out. This step is difficult and not without risk. We investigated a system of anatomical siting of the splenic flexure using computed tomography (CT). METHODS The Shrewsbury Splenic Flexure Siting (SSFS) system involves siting of the splenic flexure using the vertebral level (VL) as a reference point. We asked three surgical registrars (SRs) to analyse 20 CT scans of patients undergoing colonic resection to ascertain the anatomical site of the splenic flexure using the SSFS system. The distance from the centre of the vertebral body to the lateral edge (CVBL) of the splenic flexure was measured, as was the distance from the centre of the vertebral body to the inner abdominal wall (CVBI) along the same line, on axial images. RESULTS VL assessment demonstrated substantial inter-observer agreement with a kappa (κ) value of 0.742 (95% confidence interval (CI), 0.463-0.890). CVBL and CVBI demonstrated very strong inter-observer agreement (CVBL: κ = 0.905 (95% CI, 0.785-0.961); CVBI: 0.951 (0.890-0.979) (p<0.001). Overall, there was strong correlation between assessments by all three SRs across the three variables measured. CONCLUSIONS The SSFS system is an accurate method to site the splenic flexure anatomically using CT. We can use the SSFS system to develop a validated scoring system to help colorectal surgeons assess the difficulty of SFM.