Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development.

BACKGROUND: Support for guiding and monitoring postoperative recovery and resumption of activities is usually not provided to patients after discharge from the hospital. Therefore, a perioperative electronic health (eHealth) intervention ("ikherstel" intervention or "I recover" intervention) was developed to empower gynecological patients during the perioperative period. This eHealth intervention requires a need for further development for patients who will undergo various types of general surgical and gynecological procedures. OBJECTIVE: This study aimed to further develop the "ikherstel" eHealth intervention using Intervention Mapping (IM) to fit a broader patient population. METHODS: The IM protocol was used to guide further development of the "ikherstel" intervention. First, patients' needs were identified using (1) the information of a process evaluation of the earlier performed "ikherstel" study, (2) a review of the literature, (3) a survey study, and (4) focus group discussions (FGDs) among stakeholders. Next, program outcomes and change objectives were defined. Third, behavior change theories and practical tools were selected for the intervention program. Finally, an implementation and evaluation plan was developed. RESULTS: The outcome for an eHealth intervention tool for patients recovering from abdominal general surgical and gynecological procedures was redefined as "achieving earlier recovery including return to normal activities and work." The Attitude-Social Influence-Self-Efficacy model was used as a theoretical framework to transform personal and external determinants into change objectives of personal behavior. The knowledge gathered by needs assessment and using the theoretical framework in the preparatory steps of the IM protocol resulted in additional tools. A mobile app, an activity tracker, and an electronic consultation (eConsult) will be incorporated in the further developed eHealth intervention. This intervention will be evaluated in a multicenter, single-blinded randomized controlled trial with 18 departments in 11 participating hospitals in the Netherlands. CONCLUSIONS: The intervention is extended to patients undergoing general surgical procedures and for malignant indications. New intervention tools such as a mobile app, an activity tracker, and an eConsult were developed. TRIAL REGISTRATION: Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5686.

A Perioperative eHealth Program to Enhance Postoperative Recovery After Abdominal Surgery: Process Evaluation of a Randomized Controlled Trial.

BACKGROUND: Electronic health (eHealth) interventions have proven effective, but implementation in clinical practice is difficult. More research focusing on the implementation process of eHealth interventions is necessary. OBJECTIVE: The objective of this study was to describe the process evaluation of a perioperative eHealth intervention, aiming to enhance recovery after laparoscopic abdominal surgery. METHODS: A process evaluation was carried out alongside a multicenter randomized controlled trial. Patients aged between 18 and 75 years who were scheduled for a laparoscopic cholecystectomy, hernia inguinal surgery, or laparoscopic adnexal surgery were included. The eHealth intervention comprised a website and mobile phone app with the possibility to develop a personalized convalescence plan, a section with information about the surgical procedure and the recovery period, the possibility to ask questions via an electronic consultation (eConsult), and an activity tracker. The process evaluation was carried out using the model of Linnan and Steckler, measuring components such as reach, dose delivered, dose received, fidelity, and participants' attitudes. Implementation scores were calculated based on the average of the four components. Quantitative data were collected by means of an electronic questionnaire, a logistic database, a weblog, and medical files. Qualitative data were collected by conducting interviews with a subsample of the study participants. RESULTS: A total of 344 of the 863 eligible patients were included in the study, which accounted for a reach of 39.9%, and 173 participants were randomized to the intervention group. The implementation scores of the different functions of the intervention ranged between 60% and 65%. The website, mobile phone app, and activity tracker were rated 7.3 to 7.6 on a scale of 1 to 10. Almost all participants who were interviewed about the eConsult function rated it as being of additional value if combined with the usual care but not as a replacement for usual care. CONCLUSIONS: Although participants were overall satisfied with the intervention, the implementation scores of the different functions of the intervention were fair. More research is needed to evaluate the barriers and facilitators for implementation of this perioperative eHealth intervention in normal practice outside study setting. TRIAL REGISTRATION: Netherlands Trial Registry NTR4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6vr02V4KK).

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

BACKGROUND: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. OBJECTIVE: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. METHODS: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. CONCLUSIONS: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. CLINICALTRIAL: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).

Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial.

BACKGROUND: Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions. METHODS: We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052. FINDINGS: Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31-0·87; p=0·0131). Rates of adverse events did not differ significantly between groups. INTERPRETATION: Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions. FUNDING: Erasmus University Medical Center and Ethicon.

Small bowel perforation caused by advanced melanoma.

The incidence of melanoma has been increasing over the years and it remains, despite the heterogeneous survival for different stages, a disease with high mortality. Dissemination occurs primarily by the lymphatic route, followed by the hematogenous route. Gastrointestinal metastases do occur, but they are mainly intraluminal mucosal melanomas. Peritoneal or primary mucosal melanomas are rare. Only a few cases have been described of patients presenting with acute abdominal pain due to a melanoma. In this report we present a young patient with no prior health problems. Due to silent progression of disease at first, and secondarily avoidance of medical consultation, she finally presented to our emergency department with signs of intestinal perforation. In the operating theater a massive metastasis in the intestines with perforation was seen, as well as many smaller intra-abdominal and cutaneous lesions. Approximately 35 cm of jejunum had to be resected. Furthermore, the primary melanoma on the left forearm was excised and turned out to be in almost complete regression. Although initial recovery after surgery was good, the patient died only one month after presentation due to the advanced nature of her disease, which points to the devastating effect of undiagnosed melanoma and gastrointestinal metastasis. Since the melanoma incidence is rising, similar cases may present in the near future. This emphasizes the importance of proper full physical examination in patients with atypical abdominal symptoms.