SPONGE-assisted <i>versus</i> Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial

Fahim, Milad; Couwenberg, Alice M.; Verweij, Maaike E; Dijksman, Lea M.; Verkooijen, Helena M.; Smits, Anke B.

doi:10.1093/bjs/znac249

Cited by 6 publications

(8 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This proportion is much higher than the proportion of eligible patients usually randomized into classic RCTs, particularly RCTs involving HBOT . As observed in previous trials, the TWICS approach proved to be rather efficient, as 189 participants were enrolled in a single institution within 22 months, despite interruption of study recruitment due to COVID-19 lockdowns …”

Section: Discussionmentioning

confidence: 92%

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Mink van der Molen,

Batenburg,

Maarse

et al. 2024

JAMA Oncol

View full text Add to dashboard Cite

ImportanceHyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking.ObjectiveTo assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer.Design, Setting, and ParticipantsThis was a hospital-based, pragmatic, 2-arm, randomized clinical trial nested within the prospective UMBRELLA cohort following the trials within cohorts design in the Netherlands. Participants included 189 women with patient-reported moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer after breast irradiation. Data analysis was performed from May to September 2023.InterventionReceipt of 30 to 40 HBOT sessions over a period of 6 to 8 consecutive weeks.Main Outcomes and MeasuresBreast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points were patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were analyzed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles.ResultsBetween November 2019 and August 2022, 125 women (median [range] age at randomization, 56 [37-85] years) with late local toxic effects were offered to undergo HBOT (intervention arm), and 61 women (median [range] age at randomization, 60 [36-80] years) were randomized to the control arm. Of those offered HBOT, 31 (25%) accepted and completed treatment. The most common reason for not accepting HBOT was high treatment intensity. In ITT, moderate or severe pain at follow-up was reported by 58 of 115 women (50%) in the intervention arm and 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% (10 of 31) among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered (adjusted OR, 0.34; 95% CI, 0.15-0.80; P = .01). In ITT, moderate or severe fibrosis was reported by 35 of 107 (33%) in the intervention arm and 25 of 49 (51%) in the control arm (OR, 0.36; 95% CI, 0.15-0.81; P = .02). There were no significant differences in breast edema, movement restriction, and quality of life between groups in ITT and CACE.Conclusions and RelevanceIn this randomized clinical trial, offering HBOT to women with late local toxic effects was not effective for reducing pain, but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed. A smaller than anticipated proportion of women with late local toxic effects was prepared to undergo HBOT.Trial RegistrationClinicalTrials.gov Identifier: NCT04193722

show abstract

Section: Discussionmentioning

confidence: 92%

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Mink van der Molen,

Batenburg,

Maarse

et al. 2024

JAMA Oncol

View full text Add to dashboard Cite

show abstract

“…A study by Fahim [32] was conducted among 163 participants who were then randomized to the intervention arm, followed by informed consent. For a one-day difference (five versus six days, intervention versus control) in the duration of hospital stay, a 10% refusal rate in the intervention arm, a two-sided type one error of 5%, power 80%, and a minimum of 82 eligible participants per arm were required.…”

Section: Resultsmentioning

confidence: 99%

“…Kwakkenbos [30] blinded the statistical analysts to trial arm allocation, but were again unblinded for the complier effect analyses, which required the knowledge of intervention arm consent. Fahim [32] blinded the investigators who performed the analyses.…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review of the Statistical Methods Adopted for Analyzing Follow-Up Data in Cohort Multiple Randomized Controlled Trial

Narzari,

Nilima,

Vishnu

et al. 2024

Cureus

View full text Add to dashboard Cite

Background: The cohort multiple randomized controlled trial (cmRCT) can tackle some of the weaknesses of an RCT which has triggered the interest of researchers considerably over time. Several challenges persist regarding the methods of analyzing such valued data. The paucity of international recommendations concerning the statistical methods for analyzing trial data has led to a variety of strategies further complicating the result comparison. Our aim was to review the different cmRCT analysis methods since cmRCT was first proposed in 2010.Methodology: A search for full-length studies presenting statistical analysis of the data collected adopting a cmRCT design was conducted on PubMed, Cochrane Library, EMBASE, JSTOR, Scopus, MEDLINE, and ClinicalTrials.gov.Results: Out of 186 studies screened, we selected 22 for the full-text screening and 11 were found eligible for data extraction. All 11 studies were conducted in high-income countries, reflecting the design being underutilized in other settings. All of the studies were found to have used intention-to-treat (ITT) analysis with four of them utilizing instrumental variables (IV) analysis or a complier average causal effect (CACE). Randomization was noted often to be interchangeably used for random selection. Sample size calculation was not clearly specified in the majority of the studies. Conclusion: Clarity regarding the distinction between an RCT and a cmRCT is warranted. The fundamental difference in design, which leads to certain biases that need to be taken care of by adopting IV or CACE analysis, has to be understood before taking up a cmRCT.

show abstract

“…However, if it does occur, the availability of a cohort study offers an important advantage, because a patients’ treatment status in other TwiCs studies within the same cohort is known and can thus be taken into account when randomizing patients for a new TwiCs study. For example, in the Dutch PLCRC, the RECTAL BOOST [ 28 ] and SPONGE [ 34 ] trial are two consecutive trials and the trial status of the RECTAL BOOST trial was used as stratification factor when randomizing patients for the SPONGE trial. In contrast, when running multiple standard RCTs within a general population, other trial inclusions are not structurally collected and therefore not always known.…”

Section: Methodological Considerationsmentioning

confidence: 99%

“…The trial is initiated within the PLCRC [ 9 , 10 ] Ongoing 60 patients with circulating tumor DNA. In total, 1320 patients SPONGE [ 33 , 34 ] Clinical trial investigating the impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer. The trial is initiated within the PLCRC [ 9 , 10 ] and is a follow-up trial of the RECTAL BOOST trial.…”

Section: Overview Of (Applied) Twics In the Oncological Settingmentioning

confidence: 99%

The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections

Kessels

May

Koopman

et al. 2023

BMC Med Res Methodol

View full text Add to dashboard Cite

A Trial within Cohorts (TwiCs) study design is a trial design that uses the infrastructure of an observational cohort study to initiate a randomized trial. Upon cohort enrollment, the participants provide consent for being randomized in future studies without being informed. Once a new treatment is available, eligible cohort participants are randomly assigned to the treatment or standard of care. Patients randomized to the treatment arm are offered the new treatment, which they can choose to refuse. Patients who refuse will receive standard of care instead. Patients randomized to the standard of care arm receive no information about the trial and continue receiving standard of care as part of the cohort study. Standard cohort measures are used for outcome comparisons. The TwiCs study design aims to overcome some issues encountered in standard Randomized Controlled Trials (RCTs). An example of an issue in standard RCTs is the slow patient accrual. A TwiCs study aims to improve this by selecting patients using a cohort and only offering the intervention to patients in the intervention arm. In oncology, the TwiCs study design has gained increasing interest during the last decade. Despite its potential advantages over RCTs, the TwiCs study design has several methodological challenges that need careful consideration when planning a TwiCs study. In this article, we focus on these challenges and reflect on them using experiences from TwiCs studies initiated in oncology. Important methodological challenges that are discussed are the timing of randomization, the issue of non-compliance (refusal) after randomization in the intervention arm, and the definition of the intention-to-treat effect in a TwiCs study and how this effect is related to its counterpart in standard RCTs.

show abstract

SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial

Cited by 6 publications

References 22 publications

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer

A Systematic Review of the Statistical Methods Adopted for Analyzing Follow-Up Data in Cohort Multiple Randomized Controlled Trial

The Trial within Cohorts (TwiCs) study design in oncology: experience and methodological reflections

Contact Info

Product

Resources

About