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HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia.

ABSTRACT: Background:Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL). Methods:Subjects and sampleThere were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training.Study designThis is a feasibility study of a randomised controlled trial with 2?months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed.InterventionA theoretically informed physical activity intervention was done, targeting people with PSH.Main outcome of feasibility studyThe main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention.Other outcomesWe will evaluate 4 intervention parameters-fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients' consent rate, acceptability of study design and data availability rates for following endpoints): I.Diagnosis and classification of PSHII.Muscle activationIII.Body composition (BMI, waist circumference)IV.Patient reported outcomes: QoL, body image and physical functioningV.Physical activity;VI.Psychological determinants of physical activityOther dataIncluded are other data such as interviews with all participants about the intervention and trial procedures.Data analysis and statistical powerAs this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically. Discussion:The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression. Trial registration:ISRCTN15207595.

SUBMITTER: Hubbard G

PROVIDER: S-EPMC7517671 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia.

Hubbard Gill G Beeken Rebecca J RJ Taylor Claire C Oliphant Raymond R Watson Angus J M AJM Munro Julie J Russell Sarah S Goodman William W

Pilot and feasibility studies 20200924

<h4>Background</h4>Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increase ...[more]

PMID: 32983558

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Project description:BackgroundAspiring endoscopic surgery with extraperitoneal mesh application to avoid adhesion and pain from mesh fixation, we adopted the principles of the open Pauli repair of parastomal hernia (PSH). We have termed the procedure ePauli repair. The aim of this account is to inform about feasibility and adverse reactions.MethodsPatients with PSH selected for ePauli repair with transversus abdominis release (TAR) were enrolled in a prospective observational study. Patients were operated with laparoscopic or robotic assistance and endoscopic Rives-Stoppa repair in cases with concomitant midline hernia. Coated meshes or a buffer mesh was used in the retromuscular pocket for this modification of the Sugarbaker principle.ResultsFifteen patients were included: six patients were operated laparoscopically and nine patients with robotic assistance. The median age of the stomas was 33 months (7-313). Five PSHs were recurrent after previous repairs. Median operating time without midline hernia repair was 156 min (107-233) and with midline hernia repair 241 min (176-286). One serosa lesion arose during operation, prompting intraoperative revision of the ostomy without postoperative morbidity. Two patients had postoperative obstruction and were readmitted to operation: one with multiple adhesions and one had kinking of the stoma bowel caused by insufficient incision of the transversalis fascia. No infections or seromas have been observed. One patient had discoloring of the flank with spontaneous remission, and one patient had recurrence. Median postoperative admission time was 3 days (1-19). Median follow-up is 10 months (0-27).ConclusionsePauli repair is technically challenging but feasible. With our limited experience, we are encouraged with the pain, complication, and functional summary after ePauli repair and hopeful for the recurrence profile. ePauli/TAR is not for every patient or every surgeon and whether it should be restrained to recurrent PSH or be offered as first-line treatment for PSH is disputable.

Project description:ImportanceParastomal hernia is a challenging complication following ostomy creation; however, the incidence and long-term outcomes after elective parastomal hernia repair are poorly characterized.ObjectiveTo describe the incidence and long-term outcomes after elective parastomal hernia repair.Design, setting, and participantsUsing 100% Medicare claims, a retrospective cohort study of adult patients who underwent elective parastomal hernia repair between January 1, 2007, and December 31, 2015, was performed. Logistic regression and Cox proportional hazards models were used to evaluate mortality, complications, readmission, and reoperation after surgery. Analysis took place between February and May 2022.ExposuresParastomal hernia repair without ostomy resiting, parastomal hernia repair with ostomy resiting, and parastomal hernia repair with ostomy reversal.Main outcomes and measuresMortality, complications, and readmission within 30 days of surgery and reoperation for recurrence (parastomal or incisional hernia repair) up to 5 years after surgery.ResultsA total of 17 625 patients underwent elective parastomal hernia repair (mean [SD] age, 73.3 [9.1] years; 10 059 female individuals [57.1%]). Overall, 7315 patients (41.5%) underwent parastomal hernia repair without ostomy resiting, 2744 (15.6%) underwent parastomal hernia repair with ostomy resiting, and 7566 (42.9%) underwent parastomal hernia repair with ostomy reversal. In the 30 days after surgery, 676 patients (3.8%) died, 7088 (40.2%) had a complication, and 1740 (9.9%) were readmitted. The overall adjusted 5-year cumulative incidence of reoperation was 21.1% and was highest for patients who underwent parastomal hernia repair with ostomy resiting (25.3% [95% CI, 25.2%-25.4%]) compared with patients who underwent parastomal hernia repair with ostomy reversal (18.8% [95% CI, 18.7%-18.8%]). Among patients whose ostomy was not reversed, the hazard of repeat parastomal hernia repair was the same for patients whose ostomy was resited vs those whose ostomy was not resited (adjusted hazard ratio, 0.93 [95% CI, 0.81-1.06]).Conclusions and relevanceIn this study, more than 1 in 5 patients underwent another parastomal or incisional hernia repair within 5 years of surgery. Although this was lowest for patients who underwent ostomy reversal at their index operation, ostomy resiting was not superior to local repair. Understanding the long-term outcomes of this common elective operation may help inform decision-making between patients and surgeons regarding appropriate operative approach and timing of surgery.

Dataset Information

HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia.

Publications

HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia.

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