No Lifting Restrictions After Inguinal Hernia Repair

Overseen By Danielle Abbitt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Eastern Colorado Health Care System

Disqualifiers: Bilateral hernia, Recurrent hernia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores recovery speed after surgery for a single-sided inguinal hernia when participants choose their activity levels. One group will resume normal activities as they feel comfortable, while the other will follow standard lifting restrictions. Researchers aim to determine if earlier activity aids in faster healing and overall well-being. Individuals with a single-sided inguinal hernia scheduled for surgery might qualify for this study. As an unphased trial, it offers a unique opportunity to enhance understanding of recovery processes and potentially improve post-surgery guidelines.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients after inguinal hernia repair?

Research shows that removing lifting restrictions after inguinal hernia surgery might be safe and beneficial. Studies suggest there isn't strong evidence against resuming normal activities, like lifting, soon after surgery. Allowing individuals to move and lift at their own pace could aid faster recovery.

One study found that patients who returned to their usual activities sooner did not experience more complications. This suggests that letting patients decide when to lift might not increase their risk of post-surgery problems. Another study found that people who resumed normal activities quickly after hernia surgery recovered faster.

Overall, allowing patients to lift and move as they feel comfortable could be a safe option without adding extra risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the possibility of removing postoperative lifting restrictions after inguinal hernia repair. Traditionally, patients are advised not to lift heavy objects for several weeks to allow healing. However, this trial investigates whether patients can safely return to normal activities as soon as they feel comfortable, without waiting for a specific period. This approach could potentially speed up recovery and improve quality of life by reducing the downtime associated with conventional restrictions. If successful, it might lead to a shift in postoperative care, offering more flexibility and convenience for patients.

What evidence suggests that removing postoperative lifting restrictions is effective for inguinal hernia repair?

Research shows that after inguinal hernia surgery, strong evidence does not exist against allowing patients to resume normal activities, such as lifting, soon after the operation. In this trial, participants in the "Activity as tolerated" arm will return to activity as comfortable and stop if pain occurs. Some studies have found that immediate movement and fewer restrictions do not increase the risk of complications. In fact, having fewer activity limits for up to two weeks after minimally invasive surgery appears safe. Allowing patients to decide when to resume usual activities might aid recovery and improve quality of life. More research is needed, but early findings suggest that lifting restrictions may not be necessary for everyone. ^{1 2 3 5 6}

Who Is on the Research Team?

Edward Jones

Principal Investigator

VHAECH

Are You a Good Fit for This Trial?

This trial is for individuals with a clinical diagnosis of unilateral inguinal hernia who are scheduled for surgery and can provide consent. It's not suitable for those unable to follow the study procedures or give informed consent.

Inclusion Criteria

I have been diagnosed with a hernia on one side of my groin.

Must be able to consent

I am scheduled for surgery.

Exclusion Criteria

My groin hernia has come back after surgery.

I am scheduled for surgery with other procedures at the same time.

I have hernias on both sides of my groin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo inguinal hernia repair surgery and begin initial recovery

2-6 weeks

1 visit (in-person for surgery)

Postoperative Activity Monitoring

Participants follow assigned activity restrictions and complete questionnaires on activity levels

6 weeks

1 visit (in-person), additional virtual follow-ups

Follow-up

Participants are monitored for hernia recurrence and postoperative complications

2 years

Periodic visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Removal of postoperative lifting restrictions

Trial Overview The study tests if patients recovering from single-sided inguinal hernia surgery have better outcomes when they decide how soon to return to physical activity, compared to those following strict post-op lifting and activity restrictions.

How Is the Trial Designed?

Group I: Activity as tolerated Experimental Treatment 1 Intervention

Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".

Group II: Standard Lifting Restrictions Active Control 1 Intervention

Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials

55

Recruited

26,200+

Published Research Related to This Trial

A survey of 293 pediatric surgeons revealed significant variability in postoperative activity restrictions for children under 12 years old after common surgeries, with some surgeons recommending no restrictions at all, despite the potential risks of complications.

There is a lack of evidence supporting the necessity of these activity restrictions, which may negatively impact a child's psychosocial well-being and quality of life, highlighting the need for further research on their actual benefits and effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current practice patterns for postoperative activity restrictions in children. Baumann, LM., Williams, K., Ghomrawi, H., et al.[2019]

A 76-year-old man experienced significant improvement in chronic inguinal pain after laparoscopic removal of a mesh plug, reducing his pain score from 8 to 2 within two days and allowing him to stop pain medication by 10 months post-surgery.

The study highlights that while laparoscopic plug removal is effective and safe, there is still insufficient evidence to recommend mesh removal without accompanying triple neurectomy for chronic pain management, indicating the need for careful patient evaluation and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic plug removal for chronic pain after inguinal hernia repair using the plug-and-patch technique: A case report. Tazaki, T., Sasaki, M., Kohyama, M., et al.[2020]

A survey of 420 surgeons revealed significant variability in activity restrictions after abdominal surgery, with 53.1% recommending a 6-week hiatus from heavy lifting after open surgery, while recommendations for minimally invasive surgery varied widely from no restrictions to 6 weeks.

Only 23.8% of surgeons based their activity recommendations on existing evidence, highlighting a need for future clinical trials to establish safe and effective postoperative activity guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current surgeon practices for postoperative activity restrictions after abdominal surgery vary widely: A survey from the communities on the ACS website. Loor, MM., Dhanani, NH., Trautner, BW., et al.[2020]

Instilling bupivacaine into the pre-peritoneal space and trocar incisions during laparoscopic inguinal hernia repair significantly reduces early postoperative pain, as indicated by lower Visual Analog Scale (VAS) scores at 4 hours compared to patients who received no local anesthetic.

Patients who received bupivacaine required less analgesic medication post-surgery, demonstrating its efficacy in pain management, with no significant difference in pain relief between those receiving bupivacaine in the pre-peritoneal space and those receiving it only in the trocar incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infiltration of bupivacaine into the preperitoneal space and trocar incisions of patients undergoing laparoscopic totally extraperitoneal repair of unilateral inguinal hernia: a prospective randomized controlled observational study. Çolak, Ş., Akkuş, Ö., Gürbulak, B., et al.[2022]

A study involving 20 skilled male drivers showed that anterior tension-free hernia repair does not impair emergency stop reaction time by the second postoperative day, indicating that patients can safely resume driving shortly after surgery.

Most patients reported low pain levels post-surgery, with 90% returning to normal activities and work by the eighth postoperative day, suggesting a quick recovery and minimal disruption to daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convalescence and driver reaction time after tension-free inguinal hernia repair. Bahir, A., Lawaetz, O., Kjeldsen, L., et al.[2020]

Patients who underwent laparoscopic inguinal hernia repair returned to normal activities significantly sooner than those who had conventional repair, with a recovery time of 6 days compared to 10 days.

One week post-surgery, laparoscopic repair patients demonstrated better abdominal muscular performance and higher scores in activities of daily life, indicating a more effective recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of physical performance following laparoscopic and open inguinal hernia repair. The Coala Trial Group. Liem, MS., van der Graaf, Y., Zwart, RC., et al.[2006]

In a study of 97 Royal Naval and Royal Marine personnel, those who returned to full duties 21 days after inguinal hernia repair did not experience any complications, indicating that early return to work is safe.

A concurrent trial with 119 civilian patients showed that those encouraged to return to work immediately did so significantly faster (mean of 38 days) compared to those who received no advice (mean of 71 days), suggesting that active encouragement can help shorten recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early return to work after repair of a unilateral inguinal hernia. Taylor, EW., Dewar, EP.[2019]

In a study of 61 patients undergoing totally extraperitoneal (TEP) laparoscopic inguinal hernia repair, the majority reported only mild pain post-surgery, indicating a favorable safety profile for this technique.

The study found low rates of postoperative complications, with only a small percentage experiencing issues like seroma or hematoma, suggesting that TEP repair can effectively reduce postoperative morbidity when performed by experienced surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total extra peritoneal inguinal hernia repair: a single-surgeon preliminary findings report. Kostov, GG., Dimov, RS.[2022]

The tension-free inguinal hernia repair method using polypropylene mesh was performed on 1017 patients with no mortality and very low complication rates, including only 0.9% sepsis and 1% persistent neuralgia.

Patients experienced quick recovery times, with nearly half of office workers returning to work within a week and 61% of manual workers returning within two weeks, highlighting the method's efficacy and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tension-free mesh hernia repair: review of 1098 cases using local anaesthesia in a day unit. Kark, AE., Kurzer, M., Waters, KJ.[2018]

Inguinal hernia repair is a common surgical procedure, but the time it takes for patients to return to work varies widely, influenced by factors like patient expectations and mental health, particularly depression.

Utilizing plastic surgery techniques on the posterior wall of the inguinal canal may facilitate a quicker recovery and earlier return to work for patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Social aspect of inguinal herniotomy]. Antadze, AA.[2008]

The implementation of an Enhanced Recovery After Surgery (ERAS) protocol significantly reduced the incidence of post-operative urinary retention (POUR) from 4.2% to 1.4%) in patients undergoing minimally invasive inguinal hernia repair, indicating improved safety outcomes.

Patients discharged without narcotic prescriptions experienced a 0% rate of POUR, suggesting that minimizing narcotic use can enhance recovery and reduce complications after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A steady stream of knowledge: decreased urinary retention after implementation of ERAS protocols in ambulatory minimally invasive inguinal hernia repair. Broderick, RC., Li, JZ., Blitzer, RR., et al.[2022]

In a study of 135 patients undergoing inguinal hernia surgery, over half (57.7%) experienced activity limitations four months post-surgery, with significant predictors including older age, preoperative activity limitations, anxiety, and postoperative pain and depression.

The findings suggest that addressing preoperative anxiety and postoperative depression could help reduce activity limitations, although psychological factors explained only a small portion of the variance in these limitations, indicating a need for further research into specific cognitive factors related to activity behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation following surgery: clinical and psychological predictors of activity limitations. Powell, R., Johnston, M., Smith, WC., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05867134

Activity Restrictions After Inguinal Hernia Repair This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following ...

2. withpower.com withpower.com/trial/phase-hernia-2023-22750

No Lifting Restrictions After Inguinal Hernia Repair This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.713138/full

Recommendations on Postoperative Activities After ... However, we found no evidence against immediate mobilization, reduced physical activity, and lifting for up to 2 weeks after laparoscopic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9200870/

Recommendations on postoperative strain and physical labor ... It was found that the majority of 58–68% considered up to 2 weeks of reduced physical activity or heavy lifting after a groin hernia repair to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949711623000497

A prospective study of postoperative activity restrictions in ... We aim to compare time to resume full activity, postoperative outcomes, and describe family preferences of self-directed activity restrictions (SDAR)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7270603/

A prospective clinical trial - PMC - PubMed Central Shortened physical activity restrictions after incisional hernia repair could lead to an early return to work. Shortened physical activity restrictions have ...